Non Small Cell Lung CancerNCT05254782
Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection
An observational study of Non Small Cell Lung Cancer, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 360 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Jul 2021to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early stage (T1-T4 (T3,T4 multifocal) N0M0) non-small cell lung cancer, with planned complete surgical resection.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Michael Garron Hospital
Toronto, Ontario
Hajara Abdirahman, Hajara.Abdirahman@tehn.ca
Najib Safieddine, MD
- Recruiting
St. Joseph's Health Centre
Toronto, Ontario
Linda Karnay, (416) 530-6000 ext. 4489, Linda.Karnay@unityhealth.to
Michael Ko, MD, PhD
- Recruiting
University Health Network
Toronto, Ontario
Natasha Leighl, MD
About this study
Official 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)
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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 36 Months
Secondary outcomes (1)
Overall Survival
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.
Measured: Up to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start6 Jul 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, The Princess Margaret Cancer Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254782
- Sponsor's protocol ID
- 20-6199
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feng J, Khan S, Waddell TK, Yasufuku K, Coyne Z, Kelly D, Meti N, Safieddine N, Ko M, Pierre A, Keshavjee S, Wakeam E, Donahoe L, Cypel M, Yeung J, de Perrot M, Ahmadi N, Gazala S, Simone C, Parente D, Rabey MR, Law JH, Li JJN, Salvarrey A, Le LW, Seto A, Cabanero M, Tsao MS, Pipinikas C, Chevalier A, Bratman SV, Leighl NB. Identifying Patients With High-Risk Stage I NSCLC Using a Tumor-Informed Plasma ctDNA Assay. J Thorac Oncol. 2026 Jun;21(6):103645. doi: 10.1016/j.jtho.2026.103645. Epub 2026 Feb 21.
PubMed 41730473
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05254782
- Acronym / sponsor ID
- 20-6199
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Institute for Cancer Research, The Princess Margaret Cancer Foundation
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early stage (T1-T4 (T3,T4 multifocal) N0M0) non-small cell lung cancer, with planned complete surgical resection.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Overall Survival
Time frame: Up to 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 41730473Feng J, Khan S, Waddell TK, Yasufuku K, Coyne Z, Kelly D, Meti N, Safieddine N, Ko M, Pierre A, Keshavjee S, Wakeam E, Donahoe L, Cypel M, Yeung J, de Perrot M, Ahmadi N, Gazala S, Simone C, Parente D, Rabey MR, Law JH, Li JJN, Salvarrey A, Le LW, Seto A, Cabanero M, Tsao MS, Pipinikas C, Chevalier A, Bratman SV, Leighl NB. Identifying Patients With High-Risk Stage I NSCLC Using a Tumor-Informed Plasma ctDNA Assay. J Thorac Oncol. 2026 Jun;21(6):103645. doi: 10.1016/j.jtho.2026.103645. Epub 2026 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Rabey (416-946-4501 ext. 2259, mary.rabey@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ctDNA Detection (time frame: Up to 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.