High-precision detection of leftover cancer using a liquid-biopsy platform (SHERLOCK)

Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)

This project will test whether sensitive blood and other fluid tests for circulating tumor DNA can find leftover cancer (minimal residual disease) in adults treated with curative intent for breast, lung, melanoma, gynecologic, or genitourinary cancers.

Quick facts

• Study type: Observational
• Enrollment: 7000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (other)
• Drugs / interventions: bevacizumab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT07524114 on ClinicalTrials.gov

What this trial studies

The platform collects and sequences biospecimens (blood, tissue, urine, saliva, and surgical drainage) and links those molecular results to imaging and clinical data to detect minimal/molecular residual disease (MRD). Clinical annotation captures patient and disease characteristics, treatments, and outcomes to contextualize ctDNA findings. Patients who are MRD positive may be referred to separate interception treatment trials, while serial blood and imaging are used to monitor MRD clearance and correlate with relapse. Exploratory correlative analyses aim to improve sensitivity and interpretation of ctDNA-based MRD across multiple tumor types.

Who should consider this trial

Good fit: Adults (≥18) with confirmed cancer who have undergone or are planned for curative-intent treatment within the past 12 months, including breast, lung, melanoma, gynecologic, or genitourinary cancers, and who can provide informed consent are ideal candidates.

Not a fit: Patients with unresectable or widely metastatic disease not treated with curative intent, those more than 12 months beyond curative-intent treatment without concern for MRD, or those unable to attend required follow-up are unlikely to benefit from this platform.

Why it matters

Potential benefit: If successful, this could enable earlier detection of relapse and guide preventive treatments to extend relapse-free survival.

How similar studies have performed: Similar ctDNA-based MRD approaches have shown promising but still emerging results in some cancers (for example colorectal and lung), though broad validation across tumor types remains ongoing.

Eligibility criteria

Inclusion Criteria:

1. Patients with histopathological confirmation of cancer. Patients whose diagnosis are made by cytology may also be considered for this study. For tumor types that are typically diagnosed using unequivocal imaging findings or biomarker profiles (e.g. hepatocellular cancer, uveal melanoma), they can be eligible without histopathological or cytological confirmation.
2. Patients must have cancer that is planned for or has undergone curative intent treatment (e.g. surgery, definitive radiation, definitive chemoradiation, adjuvant radiation, adjuvant chemotherapy, adjuvant chemoradiation, etc). Curative intent treatment must be completed within 12 months of study entry. For patients on adjuvant/maintenance endocrine or biological therapy (e.g. bevacizumab, immunotherapy, etc), enrollment within 12 months of completion of curative intent treatment is allowed.
3. Patient must be ≥ 18 years old.
4. All patients must have signed and dated an informed consent form.

Exclusion Criteria:

1. History of another active invasive cancer within 2 years prior to study enrolment. Exceptions include squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 2 years.
2. Prior allogeneic stem cell transplant

Where this trial is running

Toronto, Ontario

• Princess Margaret Hospital — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Lillian Siu, MD — Princess Margaret Cancer Centre
• Study coordinator: Kimberly Vuong

Conditions: Breast Cancer, Lung Cancer, Melanoma, Gynecologic Cancer, Genitourinary Cancer, Pancreatobiliary Cancer, Gastrointestinal Cancer, Head and Neck Cancer