The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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.
ClinicalTrials.gov Identifier: NCT05461430
Recruitment Status : **RECRUITING NOW**
First Posted : July 18, 2022
Last Update Posted : May 8, 2023
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Travera Inc
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Brief Summary:
The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.
Pleural Effusion, Malignant Ascites, Malignant Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Carcinoma, Renal Carcinoma, Small Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Pancreatic Ductal Carcinoma, Neuroendocrine Carcinoma, Thymic Carcinoma, Pancreatic Carcinoma Breast Carcinoma, Ovarian Carcinoma Bladder Carcinoma of Unknown Primary Carcinoma of the Head and Neck Carcinoma of the Oropharynx Carcinoma of the Larynx Carcinoma of the Bladder Carcinoma of Esophagus Carcinoma of the Nasopharynx Carcinoma of the Penis Carcinoma of the Cervix Carcinoma of the Anus Carcinoma of the Vulva Carcinoma of the Appendix Carcinoma of the Oral Cavity Cholangiocarcinoma Melanoma Mesothelioma Pancreatic Cancer
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Study Type :
Observational
Estimated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance
Actual Study Start Date :
July 15, 2022
Estimated Primary Completion Date :
July 2025
Estimated Study Completion Date :
July 2026
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
BOR [ Time Frame: 12 months ]
Best overall response
Secondary Outcome Measures :
PFS [ Time Frame: 24 months ]
Progression Free Survival
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Probability Sample
This pilot study will utilize samples from as many as 200 patients with a known carcinoma undergoing routine draining of malignant fluids or sampling of their tumor tissue for diagnostic or palliative standards of care (SOC).
Inclusion Criteria:
Patient is ≥18 years of age
Written Informed Consent provided by patient
Diagnosis of any kind of carcinoma
Malignant fluid (e.g. pleural effusion or ascites) drainage OR tumor tissue resection OR tumor tissue needle biopsy is clinically indicated as part of SOC
Proceeding onto therapy for treatment
Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)
Exclusion Criteria:
Lack of informed consent
Unable to obtain sufficient sample
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05461430
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xCures
Oakland, California, United States, 94612
Contact: Sarah Ginn, MD   707-641-4475   traverastudy@xcures.com  Â
Travera Inc
xCures
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Principal Investigator:
Mark Stevens, Phd
Travera Inc
Principal Investigator:
Rob Kimmerling, Phd
Travera Inc
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Responsible Party:
Travera Inc
ClinicalTrials.gov Identifier:
NCT05461430 Â Â
Other Study ID Numbers:
TRV-003
First Posted:
July 18, 2022 Â Â Key Record Dates
Last Update Posted:
May 8, 2023
Last Verified:
May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Travera Inc:
Breast CancerLung CancerNSCLCOccult CancerOvarian CancerMelanoma
MesotheliomaGastrointestinal Stromal TumorGastric CancerColon CancerCervical Cancer
Additional relevant MeSH terms:
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CarcinomaMelanomaMesotheliomaMesothelioma, MalignantCholangiocarcinomaCarcinoma, Non-Small-Cell LungNasopharyngeal CarcinomaCarcinoma, HepatocellularUrinary Bladder NeoplasmsCarcinoma, Renal CellCarcinoma, Small CellAnus NeoplasmsCarcinoma, Pancreatic DuctalEsophageal NeoplasmsPleural Effusion, Malignant
Breast NeoplasmsVulvar NeoplasmsCarcinoma, Ovarian EpithelialCarcinoma, NeuroendocrineThymomaPleural EffusionAscitesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and Melanomas
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.
