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The investigators propose using “off-the-shelf” products in a 12-week multicomponent cognitive intervention program to address the cognitive impairment in outpatient hematologic malignancy survivors. The program includes two components: i) A modified ketogenic diet using an exogenous ketogenic supplementation using the KetoCal product ([https://shop.myketocal.com/product/ketocal-41-lq]) and ii) online cognitive training using Lumosity program (http://www.lumosity.com/).
A ketogenic diet is characterized by high fat, moderate protein and very low carbohydrate intake. Participants will follow a modified ketogenic diet consuming exogenous Ketocal tetrapaks daily to substitute ~700 calories of their daily calorie needs and limit their carbohydrate intake while maintaining an eucaloric diet. The KetoCal is a nutritionally complete, ready-to-feed ketogenic meal replacement product. The study goal is to achieve safe and tolerable levels of mild nutritional ketosis (0.5-2mmol/L betahydroxybutyrate (BHB) blood concentration). Diet education will be provided to participants on how and when to consume the KetoCal formula, foods and beverages consistent with a ketogenic diet and foods and beverages to avoid, and how to measure the ketosis using a breathalyzer daily. Safety and Tolerability monitoring will occur by recording treatment-emergent and/or treatment-related adverse events, regular monitoring of weight and satiety levels, and routine laboratory testing using fasting blood samples at baseline and 12 weeks.
The Lumosity program offers over 60 tasks in game-like format that cover the main cognitive domains: processing speed, working memory, attention and executive function. Training will involve a daily session of 5 training tasks for 12 weeks. Each time the patient is logged in for a session, a customized report will be generated by the Lumosity program to capture performance information.
Participants’ cognitive functioning will be assessed at baseline and 12 weeks using objectively measured cognitive function to estimate the preliminary efficacy of intervention program; and at 24 weeks to examine the sustained effects of the multi-component intervention program.
The findings from this project will inform a definitive phase III trial of a multi-component intervention to improve cognitive outcomes in patients with hematologic malignancy.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Brief Summary:
Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in esophageal cancer participants; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, we sought to evaluate the prognostic significance of the CRM in participants with esophageal cancer undergoing resection.
| Condition or disease | Intervention/treatment |
|---|---|
| Esophageal Cancer Esophagus Cancer | Procedure: Esophagectomy |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
PRIMARY OBJECTIVE:
I. To investigate, compared to tumor size measurement, if functional MRI biomarkers or combination of a set of functional biomarkers provide earlier prediction of responders vs. non-responders with pathological analyses of surgical specimens as the endpoints.
SECONDARY OBJECTIVES:
I. To investigate, compared to tumor size measurement, which MRI functional biomarker or combination of a set of biomarkers provides:
Ia. A more accurate assessment of residual cancer burden with pathological analyses of surgical specimens as the endpoints.
Ib. A more accurate prognosis of five-year recurrence-free survival.
II. To validate that the Shutter-Speed dynamic contrast-enhanced (DCE) MRI method, which measures tumor blood flow and vessel wall leakiness, as well as tumor metabolic activity, and was developed by OHSU investigators on the Siemens scanner platform, is a robust method for prediction and evaluation of breast cancer response to neoadjuvant chemotherapy across major MRI scanner platforms (Siemens, Philips, and General Electric).
OUTLINE:
Patients undergo dynamic contrast-enhanced (DCE)-MRI (for measuring tumor blood vessel changes) and diffusion-weighted (DW)-MRI (for measuring tumor cell density changes) together with some standard anatomic MRI scans for about 45 minutes at baseline, after first treatment cycle, at mid-point of treatment course, and after completion of neoadjuvant chemotherapy.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The field of urology currently demands better options for men diagnosed with prostate cancer, the most common solid tumor in the US and Western Europe. Recently, active surveillance has become a main alternative for patients and physicians seeking to avoid the overtreatment phenomenon associated with standard treatments. However, most men on surveillance protocols for prostate cancer end up converting to “definitive” management whether surgery or radiation within 5 years from diagnosis.
The TRANBERG®|Thermal Therapy System (Clinical Laserthermia Systems AB. Scheelevägen 2 | 223 81 Lund, Sweden), is a 25 W, 1064 nm diode laser. It uses a disposable laser applicator 14G that allows the insertion of a laser applicator (15G) with a fiberoptic core of 550µm. This thermal therapy laser system is indicated for minimal invasive ablation procedures so called Laser Induced Thermal Therapy (LITT) or also called Laser Ablation for prostate treatments. During LITT, light causes damage in tissue due to absorption of light and through heat conduction into the tissue of the absorbed energy. Light tissue interaction is reliable, reproducible, and safe. The laser fiber tip induces necrosis near the tip and coagulative effects deeper in tissues through heat conduction. The body cleans up treated tissue over time. Much experience is gained with laser ablation in different organs.
The development of medical fusion devices that incorporate the precise diagnostic findings from MRI with the flexibility of ultrasound has expanded the precision of prostate biopsies and has led thinking into the current management of prostate cancer, opening for consideration the case for partial gland ablation as an option with fewer side effects.12 Conceivably, the most promising role of fusion imaging would be in the management spectrum of prostate cancer. MRI/US fusion imaging has tremendous advantages, it delivers precise anatomical boundaries and perspectives to surgeons as they sought to destroy cancer lesions and spare healthy tissue. A better understanding on their role in ablation treatments is imperative.
The Focalyx® Fusion (Focalyx, 2140 West 68th St, #204a. Miami Lakes, FL, USA) is a novel disruptive medical device that enables an office based transperineal approach to be conducted using real-time fusion. The characteristics of this fusion device and trials studies have been well documented. This theoretically makes available a safe and laser fiber energy delivery that results in expedient and short procedure times. The Focalyx® Fusion has been used safely in the transperineal diagnosis (fusion biopsies) and management (fusion targeted cryoablation) of men with Prostate Cancer in the office setting. However, targeted prostate cryoablation carries some intrinsic disadvantages as it requires high pressure gasses. Argon and helium are not readily available worldwide, and its efficacy depends on several timely cycles demanding procedure times of about an hour or more. LITT can be accomplished in efficient minutes treatment times and can address the multi-focality of prostate cancer quite effectively. Laser ablation has proven effective when conducted in an MRI bore, however, the immensity of these machines, limited size of the bore, prone positioning and constant in and out verification makes this approach not practical. Fusion laser ablation for prostate cancer is a novel concept that can bring together the precision of MRI with the practicality of ultrasound.
The combination of the TRANBERG® laser and the FOCALYX® Fusion medical device will allow us to perform targeted transperineal fusion laser induced thermal therapy (TPF-LITT) of prostate cancer lesions. This approach portends significant advantages that the investigators can consider, among them: lesion directed ablation, sparring of critical organs and structures such as the bladder neck, NVB, urethral sphincter and rectum. Moreover, healthy tissue is spared and can perform its function, if it mirrors what the investigators have accomplished with target fusion cryoablation. It shall be expected that most men will have preservation of some ejaculation, mild changes in sexual function and no incontinence following treatment with TPF-LITT. In fact, from a urinary function status, the investigators expect patients to suffer no harm either subjectively or objectively. However, all these thoughts require rigorous evaluation. Today, there is no data or evaluation of its safety profile if/when conducted in an office setting under local anesthesia. Therefore, in this study, the principal aim is to assess tolerability and safety profile of TRANBERG® TPF-LITT conducted in men with Prostate Cancer in the office setting.
Objective: The primary objective of this study is to assess tolerability and safety, of TRANBERG® TPF-LITT in Prostate Cancer patients with clinically localized disease. The secondary objectives are to evaluate clinical performance, changes in erectile and sexual function as well as imaging volumetric changes in prostate lesions, prostate size as well as cancer control in treated areas Study design: This study is set up as open label, prospective, single center, interventional study.
Study population: Patients with low or intermediate risk prostate cancer ≥ 50 years of age.
Study Intervention: Upon meeting inclusion and exclusion criteria, subjects will undergo prostate ablation planning where the ablation areas will be noted irrespective of location so long, they are confined to this organ. The planning will allow to spare, if possible, critical structures such as the urethra, neurovascular bundles, and bladder neck. TRANBERG® TPF-LITT treatment execution will be conducted under local anesthesia using the FOCALYX® Fusion medical device as guidance for precise laser fiber localization and real-time monitoring. This investigation will employ a single fiber that will be repositioned to destroy several targeted areas to achieve the TFP-LITT goals. The surgeon will deliver the laser energy and adjust if needed. The areas treated will develop coagulative necrosis with scarring as a response to TPF-LITT. Upon conclusion of the procedure, the patient will have a multiparametric MRI of the prostate to determine the extent of ablation with this powerful technology immediately after treatment, and subsequently 1, 3 and 12 months after.
Main study parameters/endpoints: Tolerability and safety represents the main endpoints of this trial. Tolerability will be assessed during the execution of TFP-LITT. Patients will be provided with a pain analog scale and pain scores will be recorded before initiation of the procedure and during several milestones of the procedure. A final overall pain assessment will be recorded as well. Safety will be assessed during the 7-day, 30-day and 90-day clinic visits. Adverse events (AEs) will be monitored and reported using the CTCAE scale, as perioperative assessments will be conducted at each of these milestones. A grade 3 or worse AEs based on the CTCAE v5.0 within 90 days post procedure will be considered severe. Secondary outcomes will include cancer control, urinary and sexual functional outcomes. Cancer control will be measured with MRI at several milestones, serum PSA changes during the year and the definitive measure will be a Transperineal MR/US Fusion Biopsy at one year of follow up. Urinary and Sexual functional outcomes will be determined by evaluating changes in the validated questionnaires. Ejaculation will be monitored by direct questions.
The investigators aim to streamline the follow up focusing on safety according to standard of care. Patients will be instructed to contact us if they perceive any AEs. The principal investigator will oversee each patient for any AEs. Patients will be followed up in the clinic 7 days post procedure for catheter removal and AEs assessments. They will be contacted 30 days after the procedure and an AEs questionnaire will be administered as well. AEs, IPSS and SHIM assessments will be done at the 6 weeks and 3-month visits. IPSS and SHIM assessments will be done at the 6-month, 9-months and 12-months visits. Flow and volumetric studies will be conducted 3 months and 12 months from procedure date. From an oncological perspective, patients will have serum markers evaluations – PSA, Testosterone Creatinine and GFR measurements prior to a multiparametric MRI and subsequently before each MRI at months 1, 3 and 12 after TPF-LITT procedure. Critically, the Focalyx® Fusion device will be used to assess the delta changes for each lesion and overall change in prostate configuration after each MRI performed. This will allow further understanding of the speed of tissue retraction, remodeling, and spatial orientation of the treated areas for each patient. Finally at 12 months, a MR/US Transperineal fusion biopsy will be performed to assess the ablated tissue cancer sterility.
In Conclusion, TRANBERG® TPF-LITT will expose patients to potential intervention risks. However, it is our estimation and bias these potential risks will be favorable or equal to those observed with compared available standard minimal invasive treatment approaches such as active surveillance. The risks usually associated with transrectal procedures is eliminated as all treatments will performed via a transperineal access. The burden is in our opinion favorable and acceptable.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
We will calculate the mean of the four items on this subscale, as recommended by the scale’s developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.
We will calculate the mean of the four items on this subscale, as recommended by the scale’s developers, to yield a score ranging from 0 to 10; higher scores indicate more severe pain. Analyses will examine group differences in change in pain severity.
We will calculate the mean of the seven items on this subscale, as recommended by the scale’s developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.
We will calculate the mean of the seven items on this subscale, as recommended by the scale’s developers, to yield a score ranging from 0 to 10; higher scores indicate greater interference. Analyses will examine group differences in change in pain interference.
We will reverse score items as necessary, and then sum responses to the measure’s 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.
We will reverse score items as necessary, and then sum responses to the measure’s 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.
We will reverse score items as necessary, and then sum responses to the measure’s 14 items to yield a total score ranging from 0 to 42; higher scores indicate greater emotional distress. Analyses will examine group differences in change in emotional distress.
We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.
We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.
We will use the total score for the FACT-B, normalizing scores according to standard scoring methods to yield a score from 0-100; higher scores indicate greater Health-Related Quality of Life (HRQoL). Analyses will examine group differences in change in HRQoL.
Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.
Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.
Using standard scoring instructions, we will first rescore each of the 10 items on this scale to indicate adherence (=1) or non-adherence (=0), then sum them to yield a score from 0 to 10; higher scores indicate better self-reported medication adherence. Analyses will examine group differences in change in adherence.
We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in change in adherence from baseline to each of the post-intervention assessments.
We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in change in adherence from baseline to each of the post-intervention assessments.
We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in change in adherence from baseline to each of the post-intervention assessments.
We will use data from these pill bottles, gathered daily throughout the study, to compute an adherence score (percentage of days on which the prescribed dose of medication was taken) and evaluate group differences in probability of optimal adherence, using a dichotomous variable using a cutoff of <80% to identify sub-optimal adherence (where 80% or greater adherence is optimal).
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354.
IGM-7354 will be administered intravenously (IV).
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The International Rare Brain Tumor Registry (IRBTR) is a prospective observational study that will collect tumor samples and matched clinical and radiological data to better understand the outcomes of patients with rare brain tumors in particular: CNS sarcoma, BCOR, MN-1 altered tumors, and other unclassified rare brain tumors.
Data collected include demographics, disease characteristics, treatment information, radiological imaging, and biospecimen collection if available ( tumor tissues Patients will be followed longitudinally to obtain outcome data. Data collection will continue for approximately 10 years.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The objective of this Study is to collect, process, and transfer biologic samples such as blood and/or tissue biopsies to determine the concordance of detected alterations obtained through liquid biopsy analyses compared to next generation sequencing of time-matched or archival tissue specimens from individuals with advanced solid tumors.
Examples of locally advanced and metastatic tumors include stage III and IV cancers (ex. lung, breast, all gastrointestinal malignancies, all gynecologic malignancies, prostate cancer, head and neck tumors, soft tissue cancers, and melanoma). These specimens will be analyzed for diagnostic purposes and research (either by Labcorp/OmniSeq or to a third-party recipient designated by Labcorp/OmniSeq). Labcorp/OmniSeq may transfer the specimens and data to its clients, including commercial, academic or non-profit research institutions; or alternatively, may retain the specimens in its repository for future research use at the sole discretion of Labcorp/OmniSeq and or assignees. Labcorp/OmniSeq will maintain all detailed clinical information including demographic data (de-identified), ethnicity, disease state, stage (radiological, pathological and clinical-whichever is relevant).
The scope of this pilot includes increasing uptake of personalized medicine (PM) testing using the OmniSeq test for identifying actionable target mutations in clinically appropriate patients and improving the quality of care particularly in practices providing care to minority and underserved patient populations. The research scope of this pilot covers 3 major areas that are necessary to understand the feasibility and best approaches.
i. How to identify appropriate steps and strategies to improve compliance to achieve optimum testing for all cancer patients, including all minority patients, in accordance with approved guidelines.
ii. How to contact, trace and test all eligible patients and impact outcomes to prevent future cancers in unaffected relatives
iii. Impact of trace back approach to identify, test, and guide appropriate clinical management and intervention in patients already diagnosed with eligible cancer types who have not yet been tested. This can be done by: 1) searching pathology records or tumor registry databases 2) community engagement campaigns and 3) self-referral based on family (and/or personal) cancer history.
The PREFER Registry will enable Labcorp/OmniSeq to create a biorepository in addition to a registry. The benefits are as follows:
Contribution to Science:
The seven steps to establish and operationalize of Labcorp/Omniseq biorepository:
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Participants from group A (hematologic malignancies) will undergo leukapheresis followed by lymphodepletion and infusion of PRGN-3007. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0.
Participants will then receive PRGN-3007 in 3 dose levels beginning at Dose Level 1, using a standard 3+3 escalation design to determine Maximum Tolerated Dose (MTD). The target maximum doses infused at each dose level is:
Dose Level 1: 1×10^6 cells/kg Dose Level 2: 3×10^6 cells/kg Dose Level 3: 1×10^7 cells/kg
Fludarabine is an antimetabolite given prior to lymphodepletion.
Other Name: Fludara
Drug: Cyclophosphamide
Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion.
Biological: PRGN-3007
PRGN-3007 T cells are autologous T cells that are genetically modified ex vivo with the Sleeping Beauty (SB) system to express a ROR1-specific chimeric antigen receptor (ROR1 CAR), membrane bound interleukin-15 (mbIL15), a kill switch derived from truncated form of human epidermal growth factor receptor (HER1t) and include a built-in mechanism for intrinsic downregulation of programmed cell death receptor 1 (PD-1) expression on UltraCAR-T cells.The transgenes are delivered from a SB transposon which ensures co-expression all transgenes in all transfected cells. T cells are selected from the apheresis product and can be modified with the SB system to manufacture the T cells with the potential of infusing within 2 days from genetic modification.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
The purpose of this study is to determine the benefit of Cellworks Singula™ reports on physician and molecular tumor board treatment recommendations across a large set of pan-cancer indications who have already received first-line therapy. The study is also to determine the benefit of Cellworks Ventura™ reports on physician and molecular tumor board treatment recommendations across a large set of relapsed or refractory pan-cancer indications.
The primary objective of this study is to survey physicians and molecular tumor board perspectives of the benefit of Cellworks Singula™and Cellworks Ventura™ reports in facilitating treatment decisions in pan-cancer patients.
Cellworks reports aim to provide NGS-based therapy recommendations to aid the decision-making of patients, physicians, and molecular tumor boards. Cellworks reports aim to provide NGS-based therapy recommendations to aid the decision-making of patients, physicians, and molecular tumor boards.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
DrugTrialsForMoney.com is an online resource for patients looking to volunteer for paid clinical trials and other medical studies for money.
DISCLAIMER: DrugTrialsForMoney.com does not conduct clinical research. DTFM is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. Our posted listings include compensatory and non-compensatory studies to appeal to the widest variety of potential candidates. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.
