NSCLC Liquid Biopsies and Exhaled VOC

Recruiting

• Conditions: Lung Cancer; Circulating Tumor DNA

• Registration Number: NCT06707519
• Lead Sponsor: St. Joseph's Healthcare Hamilton

Brief Summary

The objective of the study is to determine the feasibility of recruiting participants and using sputum, Bronchoalveolar lavage (BAL) and exhaled Volatile Organic Compounds (VOC) in addition to blood, as biological samples for detecting mutations in extracted cell-free DNA in non-small cell lung cancer (NSCLC) patients, before and after surgery, and any recurrence within a 24-month postoperative follow-up period.

This is a pilot feasibility study, proposed as a 24-month prospective, single-center, non-interventional, observational trial with NSCLC-adenocarcinoma patients indicated for resection surgery with curative intent.

Detailed Description

Circulating tumor DNA (ctDNA) is increased in patients with lung cancer, and may allow detecting minimal residual disease and disease recurrence, preceding radiological detection. Detecting ctDNA in bronchoalveolar lavage/Sputum was never validated and may offer advantages over blood ctDNA, and serve as a novel biomarker for lung cancer surveillance. Lung cancer detection is possible with eNose systems with a high negative predictive value and allows prediction of treatment response to PD1 inhibitors, monitoring response to PD1 inhibitors and predicting the presence of EGFR mutations. it is reasonable to anticipate exhaled VOC to aid in detection of cancer recurrence.

The study propulsion is patients undergoing surgical resection with curative intent for NSCLC, adenocarcinoma subtype at St. Joseph's Healthcare Hamilton and the Firestone Institute of Respiratory Health , above 18 years, able to provide consent. The study procedure is collecting blood, sputum, BAL samples, exhaled VOC will be collected at the following time-points/visits: (i) Visit 1 (V1): pre surgical resection; (ii) V2: immediately before discharge from hospital post-resection; (iii) V3,4,5 : 6, 12, 24 months post-surgery; (iv) V6: unscheduled at any sign of recurrence. to note, blood sputum and BAL will be collected at visit 1 and 2 from everyone and at visits 3-6 only from those who harbor a mutation of interest.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-12-29
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patient must be at least 18 years of age
• Patient must be able to provide consent
• Patients undergoing surgical resection with curative intent for non-small cell lung cancer at St. Joseph's Healthcare Hamilton and Firestone Institute for Respiratory Health.

Exclusion Criteria

• Resection done with non-curative intent or metastatic disease
• other malignancies
• Patients with previously treated malignancy less than 5 years prior to current resection (not including skin cancer).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety, adverse events	December 2025	any adverse events (threshold \<10%)
Recruitment rate	December 2025	the proportion of eligible participants recruited (threshold \>75%)
Data completion rate	December 2025	proportion of samples that are usable (threshold \>80%)

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada