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Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection | Clinical Trials | Clareo Health

RECRUITING

Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)

NCT05254782•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years;
•2. Ability to provide written informed consent;
•3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•4. T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection;
•5. Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging;
•6. Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required.

Exclusion Criteria

•1. Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted.
•2. Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing.
•3. Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed.
•4. Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.
•5. Pregnancy.

Locations (3)

Michael Garron Hospital

Toronto, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Key Dates

Start Date

July 6, 2021

Primary Completion Date

March 30, 2026

Completion Date

March 30, 2027

Last Updated

December 6, 2024

Enrollment

360

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Contacts

Mary Rabey

CONTACT

416-946-4501 mary.rabey@uhn.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

Inclusion Criteria

Exclusion Criteria

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