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

Study Overview
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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.

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

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

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carcinoma-Associated Malignant Fluid<br>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<br>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<br>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)<br>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)<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 |