Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

Recruiting

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT05254782
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-06
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse Free Survival	Up to 36 Months	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.
Rate of ctDNA Detection	Up to 24 Months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 36 Months	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.

Trial Locations

Locations (3)

Michael Garron Hospital; 🇨🇦 Toronto, Ontario, Canada

St. Joseph's Health Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada