Detecting minimal residual disease in lung cancer patients after surgery
From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)
This study is testing if a blood test that looks for cancer DNA can help find leftover cancer in lung cancer patients after their surgery to see if it can improve their chances of staying cancer-free.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT05254782 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of circulating tumor DNA (ctDNA) in identifying minimal residual disease in patients with operable non-small cell lung cancer (NSCLC) following surgical resection. It focuses on patients with stage T1-T4 N0M0 NSCLC and assesses the correlation between ctDNA detection rates and relapse-free survival. The study is conducted across multiple institutions, utilizing surgical tumor specimens for ctDNA analysis to enhance post-operative monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with operable stage T1-T4 N0M0 non-small cell lung cancer scheduled for complete surgical resection.
Not a fit: Patients who have undergone prior treatment for lung cancer or those with incomplete surgical resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring for lung cancer recurrence, allowing for timely interventions.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer recurrence, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario and 2 other locations
- Michael Garron Hospital — Toronto, Ontario, Canada (Recruiting)
- St. Joseph's Health Centre — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mary Rabey
- Email: mary.rabey@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.