Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06979661
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Haystack™ ctDNA Assay — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
May 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single-Arm - ctDNA-Guided Treatment
    This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.

Primary Outcome Measure

Detection of Circulating Tumor DNA (ctDNA) Post-Surgery [ Time Frame: Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Salma Jabbour, MD
[email protected]
732-235-2465

Find similar trials in New Brunswick, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Rutgers Cancer Institute· New Brunswick, NJ

Related Studies