Status:
RECRUITING
Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Ontario Institute for Cancer Research
The Princess Margaret Cancer Foundation
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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-...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Ability to provide written informed consent;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection;
- Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging;
- Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required.
Exclusion
- Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted.
- 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.
- Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed.
- 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.
- Pregnancy.
Key Trial Info
Start Date :
July 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05254782
Start Date
July 6 2021
End Date
March 30 2027
Last Update
December 6 2024
Active Locations (3)
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1
Michael Garron Hospital
Toronto, Ontario, Canada
2
St. Joseph's Health Centre
Toronto, Ontario, Canada
3
University Health Network
Toronto, Ontario, Canada