Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs

December 5, 2023 updated by: Travera Inc
The primary objective of this study, sponsored by Travera 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 varying cancers and biopsy formats.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

630

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 Locations

  • United States
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Columbus Regional Research Institute, John B. Amos Cancer Center
        • Contact:
          • Shelby Zikeli
          • Phone Number: 706-321-0495

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

Non-Probability Sample

Study Population

General population with cohort matched diagnoses.

Description

Inclusion Criteria:

  • Sample collection or biopsy of tumor is clinically indicated as part of SOC
  • Prior to preceding onto therapy for treatment

Exclusion Criteria:

  • 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

Cohorts and Interventions

Group / Cohort
Carcinoma-Associated Malignant Fluid
Diagnosis of any kind of carcinoma with a malignant fluid (pleural effusion or ascites) where drainage is clinically indicated as part of SOC, and a new course of treatment is upcoming.
Carcinoma Solid Tissue Specimen
Diagnosis of any kind of carcinoma where a needle biopsy or tissue resection is clinically indicated as part of SOC, and a new course of treatment is upcoming.
Multiple Myeloma
Diagnosis of relapsed multiple myeloma where bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.
Acute myelogenous leukemia (AML)
Diagnosis of acute myelogenous leukemia where a blood draw or bone marrow biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.
Triple Negative Breast Cancer (TNBC)
Diagnosis of Stage IV Triple Negative Breast Cancer where a needle biopsy is clinically indicated as part of SOC, and a new course of treatment is upcoming.
Peripheral Blood Cell Immune Competency
Diagnosis of any cancer where a blood draw is clinically indicated as part of SOC, a new course of treatment is upcoming, and checkpoint inhibitor therapy being considered for next line of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response (BOR)
Time Frame: up to 24 months
The best overall response to therapy over 24 months will be captured for correlation with test outcomes.
up to 24 months

Collaborators and Investigators

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

Sponsor

Travera Inc

Collaborators

John B. Amos Cancer Center

Investigators

  • Principal Investigator: Mark Stevens, Ph.D., Travera Inc
  • Principal Investigator: Robert Kimmerling, Ph.D., Travera Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRV-002

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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