Clinical trial · Observational
Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)
NCT05254782CI-TRIAL-00114047recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Rate of ctDNA Detection
- timeFrame
- Up to 24 Months
- description
- The percentages of pre-operative and post-operative ctDNA detection in patients with T1-T4N0 (T3, T4 multifocal) NSCLC will be estimated together with their Clopper-Pearson exact 95% CIs.
- measure
- Relapse Free Survival
- timeFrame
- Up to 36 Months
- description
- Relapse free survival (RFS) will be estimated using the Kaplan-Meier method and compared using the logrank test among patients with and without detectable ctDNA pre- or post-operatively.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 36 Months
- description
- Overall survival (OS) will be estimated using the Kaplan-Meier method and compared using the log-rank test between patients with and without detectable ctDNA pre- or post-operatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years; 2. Ability to provide written informed consent; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection; 5. Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging; 6. Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required. Exclusion Criteria: 1. Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted. 2. Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing. 3. Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed. 4. Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. 5. Pregnancy.
References
Publications (1)
- DERIVEDFeng J, Khan S, Waddell TK, Yasufuku K, Coyne Z, Kelly D, Meti N, Safieddine N, Ko M, Pierre A, Keshavjee S, Wakeam E, Donahoe L, Cypel M, Yeung J, de Perrot M, Ahmadi N, Gazala S, Simone C, Parente D, Rabey MR, Law JH, Li JJN, Salvarrey A, Le LW, Seto A, Cabanero M, Tsao MS, Pipinikas C, Chevalier A, Bratman SV, Leighl NB. Identifying Patients With High-Risk Stage I NSCLC Using a Tumor-Informed Plasma ctDNA Assay. J Thorac Oncol. 2026 Jun;21(6):103645. doi: 10.1016/j.jtho.2026.103645. Epub 2026 Feb 21. PMID 41730473