Recruiting

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05921474

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Non Small Cell Lung Cancer

Study ID

NCT05921474

Start date

Apr 3, 2023

Status verified date

Jun, 2023

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Unbiopsied, Presumed Stage I/IIA NSCLC Undergoing SABR

The first cohort will be comprised of patients with suspected stage I/IIA NSCLC with plans to undergo curative SABR.

Patients with Stage I-IIA NSCLC Undergoing SABR

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 outcome measure

  • To assess whether liquid biopsy for molecular residual disease during follow-up can predict a recurrence of lung cancer. [ Time Frame: End of study (approximately Dec 2023) ]

Central Contacts and Locations

Central contacts

Daniel Breadner, MD

519-685-8640Daniel.Breadner@lhsc.on.ca

David Palma, MD

519-685-8500David.Palma@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jun 27, 2023

Last verified

Jun, 2023

Keywords

  • Early Stage Lung Cancer
  • Stage I/IIA
  • Tumor stage T1-T2b

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-06-27.