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

Sponsor
Travera LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04985357
Collaborator
John B. Amos Cancer Center (Other)
100
Enrollment
1
Location
18
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study, sponsored by Travera LLC 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. Cohorts include patients with stage III or IV breast cancer, stage III or IV lung cancer, active AML, and relapsed multiple myeloma. This pilot study will utilize samples from patients undergoing routine biopsy of their tumor as part of their clinical care (e.g. for clinical diagnosis, staging, DNA molecular analysis). This study will involve additional material from the same procedure the patient is already undergoing.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Defining the Clinical Potential of Mass Response as a Biomarker for Patient
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Breast Cancer

    Diagnosis of stage III or IV breast cancer
    Lung Cancer

    Diagnosis of stage III or IV lung cancer
    Acute myelogenous leukemia (AML)

    Diagnosis of acute myelogenous leukemia.
    Multiple Myeloma

    Diagnosis of relapsed multiple myeloma

    Outcome Measures

    Primary Outcome Measures

    1. Best overall response (BOR) [4 months, up to 24 months]

      The best overall response to therapy will be captured for correlation with test outcomes. The duration of this best overall response assessment will be 4-months for AML and MM, and 4-months up to 24-months for breast and lung cancer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Biopsy of tumor is clinically indicated as part of SOC

    • Prior to preceding onto therapy for treatment

    Exclusion Criteria:
    • Unable to obtain sufficient sample

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbus Regional Research Institute, John B. Amos Cancer Center Columbus Georgia United States 31904

    Sponsors and Collaborators

    • Travera LLC
    • John B. Amos Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Travera LLC
    ClinicalTrials.gov Identifier:
    NCT04985357
    Other Study ID Numbers:
    • TRV-002
    First Posted:
    Aug 2, 2021
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Lung Neoplasms
    Multiple Myeloma

    Study Results

    No Results Posted as of Jul 15, 2022