Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05254782

Enrollment

360

Registered

2022-02-24

Start date

2021-07-06

Completion date

2028-03-31

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

Canada

Contacts

CONTACTMary Rabey

mary.rabey@uhn.ca416-946-4501

Outcome results