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NOT YET RECRUITING
NCT06979661
EARLY_PHASE1

Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

Summary

Primary Objective: Evaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy. Secondary Objectives: Evaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status Exploratory Objective: Evaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.

Official title: Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-06-01

Completion Date

2029-06-01

Last Updated

2025-05-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Haystack™ ctDNA Assay

A personalized, tumor-informed circulating tumor DNA (ctDNA) test that analyzes blood samples to detect minimal residual disease (MRD) and guide postoperative treatment decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) following surgical resection. The test results will help determine whether patients should receive postoperative radiation therapy (PORT) and/or systemic therapy adjustments.

Locations (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, United States