RecruitingNot Applicable

Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

Canada360 participantsStarted 2021-07-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of ctDNA Detection

Timeframe: Up to 24 Months

Relapse Free Survival

Timeframe: Up to 36 Months

Trial details

NCT IDNCT05254782

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-31

Contact for this trial

Mary Rabey

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

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials