Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance (TraveraRTGx)

Study Purpose

The primary objective of this study, sponsored by Travera Inc. 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 various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.

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:

1. Patient is ≥18 years of age. 2. Written Informed Consent provided by patient. 3. Diagnosis of any kind of carcinoma. 4. Malignant fluid (e.g. pleural effusion or ascites) drainage OR tumor tissue resection OR tumor tissue needle biopsy is clinically indicated as part of SOC. 5. Proceeding onto therapy for treatment. 6. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)

Exclusion Criteria:

1. Lack of informed consent. 2. 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.

NCT05461430
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, PhdRob Kimmerling, Phd
Principal Investigator Affiliation Travera IncTravera Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pleural Effusion, Malignant, Ascites, Malignant, Carcinoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Carcinoma, Renal, Carcinoma, Small Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Pancreatic Ductal, Carcinoma, Neuroendocrine, Carcinoma, Thymic, Carcinoma, Pancreatic, Carcinoma Breast, Carcinoma, Ovarian, Carcinoma Bladder, Carcinoma of Unknown Primary, Carcinoma of the Head and Neck, Carcinoma of the Oropharynx, Carcinoma of the Larynx, Carcinoma of the Bladder, Carcinoma of Esophagus, Carcinoma of the Nasopharynx, Carcinoma of the Penis, Carcinoma of the Cervix, Carcinoma of the Anus, Carcinoma of the Vulva, Carcinoma of the Appendix, Carcinoma of the Oral Cavity, Cholangiocarcinoma, Melanoma, Mesothelioma, Pancreatic Cancer

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

xCures, Oakland, California

Status

Recruiting

Address

xCures

Oakland, California, 94612

Site Contact

Sarah Ginn

[email protected]

707-641-4475

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