Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

NCT05254782 | Recruiting

• 1 other identifier: 20-6199
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 3

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Overall Survival

  Up to 36 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Early stage (T1-T4 (T3,T4 multifocal) N0M0) non-small cell lung cancer, with planned complete surgical resection.

You may qualify 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 qualify 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ontario Institute for Cancer Research: collaborator
• The Princess Margaret Cancer Foundation: collaborator

Study Sites (3)

Michael Garron Hospital

Toronto, Ontario, Canada

RECRUITING

St. Joseph's Health Centre

Toronto, Ontario, Canada

RECRUITING

University Health Network

Toronto, Ontario, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, plasma, buffy coat

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mary Rabey

CONTACT

416-946-4501; mary.rabey@uhn.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: July 6, 2021
• Primary Completion: March 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CA (3)