Clinical Trial Record

Return to Clinical Trials

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


2024-11


2028-05


2030-05


0

Study Overview

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

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.

N/A

  • Stage III Breast Cancer
  • Stage IV Breast Cancer
  • Stage III Lung Cancer
  • Stage IV Lung Cancer
  • AML
  • Multiple Myeloma in Relapse
  • Carcinoma
  • Carcinoma, Pancreatic
  • Carcinoma of Lung
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma Breast
  • Carcinoma Prostate
  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
  • Carcinoma, Neuroendocrine
  • Carcinoma, Small Cell Lung
  • Carcinoma, Ovarian
  • Carcinoma Bladder
  • Carcinoma of Esophagus
  • Carcinoma Cervix
  • Carcinoma, Thymic
  • Carcinoma, Ductal
  • Carcinoma of the Head and Neck
  • Carcinoma of the Lip
  • Carcinoma of the Oral Cavity
  • Carcinoma of Unknown Primary
  • Carcinoma of the Skin
  • Carcinoma of the Anus
  • Carcinoma of the Larynx
  • Carcinoma of the Penis
  • Carcinoma of the Oropharynx
  • Carcinoma of the Appendix
  • Carcinoma of the Paranasal Sinus
  • Carcinoma of the Vulva
  • Malignant Pleural Effusion
  • Malignant Ascites
  • Mesothelioma
  • Cholangiocarcinoma
    • TRV-002

    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 Registration Dates Results Reporting Dates Study Record Updates

    2021-07-15  

    N/A  

    2024-11-21  

    2021-07-28  

    N/A  

    2024-11-25  

    2021-08-02  

    N/A  

    2024-11  

    Study Plan

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

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : 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.

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Best overall response (BOR)The best overall response to therapy over 24 months will be captured for correlation with test outcomes.up to 24 months
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    Contacts and Locations

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

    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.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:

      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

    Collaborators and Investigators

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


      • PRINCIPAL_INVESTIGATOR: Mark Stevens, Ph.D., Travera Inc

      Publications

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

      General Publications

      No publications available