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

Recruiting

• Conditions: Carcinoma, Renal; Carcinoma; Carcinoma of Unknown Primary; Carcinoma of the Larynx; Carcinoma of Esophagus; Carcinoma of the Cervix; Carcinoma of the Vulva; Pancreatic Cancer; Ascites, Malignant; Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT05461430
• Lead Sponsor: Travera Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-13
• Study Start: 2022-07-15
• Study First Posted: 2022-07-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BOR	12 months	Best overall response

Secondary Outcome Measures

Name	Time	Method
PFS	24 months	Progression Free Survival

Trial Locations

Locations (1)

xCures; 🇺🇸 Oakland, California, United States