Recruiting

ctDNA

Sponsor:

University Health Network, Toronto

Code:

NCT05254782

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05254782

Start date

Jul 6, 2021

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Rate of ctDNA Detection [ Time Frame: Up to 24 Months ]
  • Relapse Free Survival [ Time Frame: Up to 36 Months ]

Central Contacts and Locations

Central contacts

Locations

Michael Garron Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Hajara Abdirahman

Hajara.Abdirahman@tehn.ca

Principal Investigator:

Najib Safieddine, MD

St. Joseph's Health Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Michael Ko, MD, PhD

University Health Network

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-09.