NSCLC Liquid Biopsies and Exhaled VOC
A Prospective, Single Center Study to Test the Validity and Feasibility of Circulating Tumor DNA in Blood, Sputum and Alveolar Fluid, as Well as Exhaled Volatile Organic Compounds as Biomarkers in Non-Small Cell Lung Cancer
1 other identifier
observational
210
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2027
April 22, 2026
April 1, 2026
4.9 years
November 25, 2024
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Recruitment rate
the proportion of eligible participants recruited (threshold \>75%)
December 2025
Data completion rate
proportion of samples that are usable (threshold \>80%)
December 2025
Safety, adverse events
any adverse events (threshold \<10%)
December 2025
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 25, 2024
First Posted
November 27, 2024
Study Start
February 1, 2023
Primary Completion (Estimated)
December 29, 2027
Study Completion (Estimated)
December 29, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04