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

NCT ID: NCT04985357

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2030-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Travera Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Stevens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Travera Inc

Robert Kimmerling, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Travera Inc

Related Links

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Other Identifiers

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TRV-002

Identifier Type: -

Identifier Source: org_study_id

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