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Detection of Circulating Tumor DNA After Stereotactic Ablative Radiotherapy in Patients With Unbiopsied Lung Tumors

Non Small Cell Lung Cancer

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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.

Study Location

London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Study Sponsored By
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Participants Required
More Information
Study ID: NCT05921474