Clinical trial · Observational
Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors
- 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)
The goal of this observational study is to determine if liquid biopsies from patients with stage I non-small cell lung cancer (NSCLC) can add to the diagnosis of a small lung cancer, or can better detect recurrent lung cancer compared to the standard of care procedures used for diagnosing this type of cancer. The main question\[s\] it aims to answer are: * Primary Objective: 1\) To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer * Secondary Objectives: 1. To assess the impact of SABR on detection rates of ctDNA in patients undergoing SABR for early-stage lung tumors. 2. To correlate positivity by blood-based cancer detection platforms and pre-treatment probability of malignancy using the Brock and Herder models. Study investigators will also assess the rate of detection for targetable mutations in this patient population, and to correlate ctDNA findings, in patients without tissue confirmed disease. Blood samples from participants will collected at eight (8) time-points: before the participant's first radiation treatment, following their first treatment and then at their 3-month, 6-month, 9-month, 12-month, 18-month and 24-month follow-up visits.
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
Design
Arms and outcomes
Arms (2)
- label
- Patients with Unbiopsied, Presumed Stage I/IIA NSCLC Undergoing SABR
- description
- The first cohort will be comprised of patients with suspected stage I/IIA NSCLC with plans to undergo curative SABR.
- label
- Patients with Stage I-IIA NSCLC Undergoing SABR
- description
- The second cohort will be comprised of patients with biopsy proven NSCLC, with clinically staged I/IIA disease with a plan to undergo definitive therapy with SABR.
Primary outcomes (1)
- measure
- To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer.
- timeFrame
- End of study (approximately Dec 2023)
- description
- Percentage of patients with MRD detected prior to or at the time of radiological recurrence, with longitudinal monitoring of ctDNA
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Willing to provide informed consent * Undergoing SABR for a solitary pulmonary nodule (SPN) with tissue confirmation or those without tissue confirmation of malignancy, must have a pretreatment likelihood of malignancy of ≥ 60% using either the Herder or Brock models (60% probability was chosen to have a reasonable chance that there will indeed be cancer in the nodule; however, most patients are expected to have a pretreatment probability of \> 85%). * Tumor stage T1-T2b (≤ 5 cm) * No evidence of nodal or distant metastases * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 Exclusion Criteria: * Contraindications to radiotherapy * Prior history of any invasive malignancy within 5 years, which might interfere with the interpretation of the ctDNA results. Non-melanoma skin cancer is allowed if under appropriate control.
References
Publications (1)
- DERIVEDVerma S, Young S, Kennedy TAC, Carvalhana I, Black M, Baer K, Churchman E, Warner A, Allan AL, Izaguirre-Carbonell J, Dhani H, Louie AV, Palma DA, Breadner DA. Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors (SABR-DETECT). Clin Lung Cancer. 2024 Mar;25(2):e87-e91. doi: 10.1016/j.cllc.2023.11.013. Epub 2023 Dec 1. PMID 38101984