Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

Non Small Cell Lung Cancer Clinical Trial

Official title:

From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254782
• Other study ID #: 20-6199
• Status: Recruiting
• Start date: July 6, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: University Health Network, Toronto
• Contact: Mary Rabey
• Phone: 416-946-4501
• Email: mary.rabey[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm, Residual
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Canada	Michael Garron Hospital	Toronto	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Inivata, Ontario Institute for Cancer Research, The Princess Margaret Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ctDNA Detection	The percentages of pre-operative and post-operative ctDNA detection in patients with T1-T4N0 (T3, T4 multifocal) NSCLC will be estimated together with their Clopper-Pearson exact 95% CIs.	Up to 24 Months
Primary	Relapse Free Survival	Relapse free survival (RFS) will be estimated using the Kaplan-Meier method and compared using the logrank test among patients with and without detectable ctDNA pre- or post-operatively.	Up to 36 Months
Secondary	Overall Survival	Overall survival (OS) will be estimated using the Kaplan-Meier method and compared using the log-rank test between patients with and without detectable ctDNA pre- or post-operatively.	Up to 36 Months