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

January 2, 2024 updated by: Travera Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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).

Description

Inclusion Criteria:

  1. Patient is ≥18 years of age
  2. Written Informed Consent provided by patient
  3. Diagnosis of any kind of carcinoma
  4. 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
  5. Proceeding onto therapy for treatment
  6. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)

Exclusion Criteria:

  1. Lack of informed consent
  2. Unable to obtain sufficient sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOR
Time Frame: 12 months
Best overall response
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 24 months
Progression Free Survival
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Travera Inc

Collaborators

xCures

Investigators

  • Principal Investigator: Mark Stevens, Phd, Travera Inc
  • Principal Investigator: Rob Kimmerling, Phd, Travera Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRV-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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