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

Travera

Status: Enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05461430

TRV-003

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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