Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Michael Garron Hospital, Toronto, Ontario, Canada
• St. Joseph's Health Centre, Toronto, Ontario, Canada
• University Health Network, Toronto, Ontario, Canada

Who to contact

Mary Rabey · 416-946-4501 · mary.rabey@uhn.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05254782.