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

NCT05461430 — Completed, 72 participants, Travera Inc

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

Registry	NCT05461430, acronym TraveraRTGx
Status	Completed
Study type	Observational
Enrollment	72 (Actual)
Sponsor	Travera Inc (Industry); collaborators: xCures
Conditions	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
Dates	start 2022-07-15, primary completion 2026-03-23, completion 2026-03-23, first posted 2022-07-18, last updated 2026-04-13
Locations	1 site in United States

-Summary

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.

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+Outcome measures

Primary outcomes

BOR [12 months]: Best overall response

Secondary outcomes

PFS [24 months]: Progression Free Survival

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
xCures	Oakland, California	United States

+Investigators

Mark Stevens, Phd, Principal investigator, Travera Inc
Rob Kimmerling, Phd, Principal investigator, Travera Inc