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

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ClinicalTrials.gov Identifier: NCT04985357
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : July 15, 2022
Sponsor:
Collaborator:
John B. Amos Cancer Center
Information provided by (Responsible Party):
Travera LLC

Study Description
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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
Stage III Breast Cancer Stage IV Breast Cancer Stage III Lung Cancer Stage IV Lung Cancer AML Multiple Myeloma in Relapse

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Defining the Clinical Potential of Mass Response as a Biomarker for Patient
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Best overall response (BOR) [ Time Frame: 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
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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:   Non-Probability Sample
Study Population
General population with cohort matched diagnoses.
Criteria

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
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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): NCT04985357


Contacts
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Contact: Mark Stevens, Ph.D. 6172999784 trv002@travera.com

Locations
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United States, Georgia
Columbus Regional Research Institute, John B. Amos Cancer Center Recruiting
Columbus, Georgia, United States, 31904
Contact: Grayson Scott    706-660-6449      
Sponsors and Collaborators
Travera LLC
John B. Amos Cancer Center
Investigators
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Principal Investigator: Mark Stevens, Ph.D. Travera LLC
Principal Investigator: Robert Kimmerling, Ph.D. Travera LLC
More Information
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Additional Information:

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Responsible Party: Travera LLC
ClinicalTrials.gov Identifier: NCT04985357    
Other Study ID Numbers: TRV-002
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
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
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Multiple Myeloma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Plasma Cell
 Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases