Clinical trial · Interventional
Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy
Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Recurrent | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haystack™ ctDNA Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-Arm - ctDNA-Guided Treatment
- description
- This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.
- interventionNames
- Diagnostic Test: Haystack™ ctDNA Assay
Primary outcomes (1)
- measure
- Detection of Circulating Tumor DNA (ctDNA) Post-Surgery
- timeFrame
- Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery
- description
- This outcome will assess the presence or absence of circulating tumor DNA (ctDNA) in blood samples collected at multiple time points following surgical resection of Stage II-III non-small cell lung cancer (NSCLC). The Haystack™ ctDNA assay will be used to detect minimal residual disease (MRD), and results will be evaluated for their ability to predict recurrence and guide postoperative radiation and systemic therapy decisions.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have provided signed informed consent for the trial 2. Aged ≥18 years at the time of informed consent 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 4. Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor 5. No active second cancers/malignancy 6. Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible 7. Willing and able to comply with all aspects of the protocol 8. Standard of care therapy and methods as per institution and investigator discretion - Exclusion Criteria: Exclusion Criteria 1. Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent 2. With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician. 3. Have known active CNS metastases and/or carcinomatous meningitis. 4. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis. 5. Have a history of interstitial lung disease. 6. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -
References
Publications (0)
Data not yet available