Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)

Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)

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:  
18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  
All

Accepts Healthy Volunteers:  
No

Sampling Method:  
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   

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    

Other Study ID Numbers:
TRV-003

First Posted:
July 18, 2022    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.

May 9, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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