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NSCLC Liquid Biopsies and Exhaled VOC

NCT ID: NCT06707519

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-29

Brief Summary

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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

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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.

Conditions

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Lung Cancer Circulating Tumor DNA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Yaron Shargall

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Layla Halwagi, BSc

Role: CONTACT

[email protected]
905-522-1155 ext. 31433

Facility Contacts

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Layla Halwagi, BSc

Role: primary

[email protected]
905-522-1155 ext. 31433

Other Identifiers

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14065

Identifier Type: -

Identifier Source: org_study_id