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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04985357
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Travera Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mark Stevens, Ph.D.Robert Kimmerling, Ph.D.
Principal Investigator Affiliation	Travera IncTravera Inc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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 Website:	View Trial Website

Arms & Interventions

Arms

: 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.

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Mark Stevens, Ph.D.

[email protected]

6172999784

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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