Clinical trial · Observational
Role of Circulating Tumor DNA (ctDNA) From LIquid Biopsy in Early Stage NSCLC Resected Lung Tumor Investigation
NCT03553550CI-TRIAL-00048361LIBERTIterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment futility
Summary
Brief summary (as posted)
The purpose of this research study is to learn more about changes in cell-free tumor DNA in blood samples, also known as a liquid biopsy, as they relate to treatment and response to treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biospecimen collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To correlate the presence of ctDNA following complete surgical resection with disease-free survival.
- timeFrame
- June, 2023
- description
- Correlation between ctDNA after surgery and disease-free survival, defined as the time from surgical resection to the earliest event defined as disease recurrence, death or new lung cancer.
Secondary outcomes (1)
- measure
- To evaluate the relation between changes in ctDNA during surveillance and tumor relapse
- timeFrame
- June, 2023
- description
- Evaluate the changes in ctDNA after complete resection at pre-specified intervals and correlate the presence of ctDNA with overall survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female aged 18 years and over 2. Planned surgical resection of NSCLC, stage IB ≥ 4 cm, II or IIIA according to the 8th edition of TNM classification16. 1. Cohort #1: Neoadjuvant Therapy - For patients who will receive neoadjuvant therapy, enrollment occurs prior to the initiation of treatment. Patients undergoing neoadjuvant therapy who achieved tumor reduction, are eligible based on baseline radiographic staging. 2. Cohort #2: Pre-Surgery - For patients identified prior to planned surgical resection, enrollment occurs within 30 days of the planned surgery. Eligibility is based on surgical pathology. 3. Cohort #3: Post-Surgery - For patients identified post-surgical resection, enrollment occurs prior to the initiation of adjuvant therapy. Eligibility is based on surgical pathology. 3. Patients with positive margins and those requiring adjuvant radiation therapy are eligible. 4. Patients with a secondary malignancy that was treated with curative intent and without evidence of relapse for at least 5 years. 5. Willingness to undergo all study collection procedures and follow up. 6. Provision of written informed consent Exclusion Criteria: 1. Male or female aged less than 18 years 2. NSCLC disease other than stated above 3. Patients with a secondary malignancy that was not treated with curative intent or has had a disease relapse in the past 5 years. 4. Unwilling to undergo all study collection procedures and follow up. 5. Unable or unwilling to provide consent.
References
Publications (0)
Data not yet available
No reference posted for this study.