TraveraRTGx: Mass Response of Malignant Fluid Cells as a Biomarker for Rapid Therapy Guidance

Sponsor

Travera LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05461430

Collaborator

xCures (Industry)

200

Enrollment

Location

47.5

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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 malignant fluids such as pleural effusions and ascites.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion, Malignant Ascites, Malignant Carcinoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mass Response of Malignant Fluid Cells as a Biomarker for Rapid Therapy Guidance

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Outcome Measures

Primary Outcome Measures

BOR [12 months]
Best overall response

Secondary Outcome Measures

PFS [24 months]
Progression Free Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is ≥18 years of age
Written Informed Consent provided by patient
Diagnosis of any kind of carcinoma
Malignant fluid (e.g. pleural effusion or ascites) drainage is clinically indicated as part of SOC
Proceeding onto therapy for treatment
Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)