Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
Non Small Cell Lung CancerctDNALung-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.
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Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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.
Lieu de l'étude
University Health Network
University Health NetworkToronto, Ontario
Canada
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Natasha Leighl, MD
Michael Garron Hospital
Michael Garron HospitalToronto, Ontario
Canada
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St. Joseph's Health Centre
St. Joseph's Health CentreToronto, Ontario
Canada
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- Étude parrainée par
- University Health Network, Toronto
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05254782