Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
NCT ID: NCT05254782
Last Updated: 2024-12-06
Study Results
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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RECRUITING
360 participants
OBSERVATIONAL
2021-07-06
2027-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ontario Institute for Cancer Research
OTHER
The Princess Margaret Cancer Foundation
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Michael Garron Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Hajara Abdirahman
Role: primary
Linda Karnay
Role: primary
Natasha Leighl, MD
Role: primary
Other Identifiers
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20-6199
Identifier Type: -
Identifier Source: org_study_id