Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
Recruiting · NCT05254782 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →What this trial 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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
3 locations listed.
- Michael Garron Hospital - Toronto, Ontario, Canada
- St. Joseph's Health Centre - Toronto, Ontario, Canada
- University Health Network - Toronto, Ontario, Canada