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NCT Number: NCT05254782

Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michael Garron Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Rate of ctDNA Detection

    Time frame: 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.

  2. Relapse Free Survival

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Rabey

CONTACT

[email protected]

416-946-4501 ext. 2259

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Ontario Institute for Cancer Research
  • The Princess Margaret Cancer Foundation

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Feb 24, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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