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

This study will collect, annotate, and sequence biospecimens (blood, tissue, urine, saliva and surgery drainage) from patients across different cancer types to detect molecular residual disease (MRD). Imaging scans and clinical data will also be gathered. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types. Results of ctDNA testing will be provided for clinical decisions and to determine eligibility for other linked interventional interception therapeutic studies, each of which will have a separate protocol.

Study Overview

• Status: Recruiting
• Conditions: Melanoma; Breast Cancer; Head and Neck Cancer; Gynecologic Cancer; Lung Cancer; Gastrointestinal Cancer; Unknown Primary Tumors; Genitourinary Cancer; Rare Cancer; Pancreatobiliary Cancer

Detailed Description

Advances in the detection and characterization of circulating tumor DNA (ctDNA) have enabled the introduction of "liquid biopsies" into clinical practice. Results from ctDNA testing of patients with certain advanced tumors (e.g., non-small cell lung cancer) are routinely used to inform decisions about drug treatment. With technological advances that improve the sensitivity of detection of ctDNA, a logical application is to apply ctDNA testing to potentially curable malignancies in patients who are at high risk of harboring minimal/molecular residual disease (MRD).

SHERLOCK is a platform study for the analysis of MRD using ctDNA in patients treated with curative intent for cancer. Exploratory and correlative analyses will also be conducted in order to investigate improved methods for MRD detection and interpretation. Clinical annotation will be performed to collect relevant patient and disease characteristics, treatment and outcomes.

Patients who are determined to be MRD positive may proceed to participate in interception clinical trials that are outside of this study's specified investigations. While on treatment, patients will continue to have blood and radiological imaging collected to measure for clearance of MRD and to correlate with outcomes.

Additional information about the SHERLOCK study is available at https://www.uhn.ca/sherlock.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Kimberly Vuong; Phone Number: 437-676-6598; Email: Gilgan.Centre@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Hospital
      • Principal Investigator: Lillian Siu, MD
      • Principal Investigator: Scott Bratman, MD
      • Contact: Kimberly Vuong; Phone Number: 437-676-6598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Early stage or locally advanced disease that is planned for or have undergone curative treatment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To collect, annotate, and analyze biospecimens for the detection of MRD	5 years
To determine the prevalence of MRD over time across tumor types	5 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Create a long-term collection of blood test data and medical information to track how cancer-related DNA changes over time.	5 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Lillian Siu, MD, Princess Margaret Cancer Centre; Principal Investigator: Scott Bratman, MD, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Liquid Biopsy; Circulating Tumor DNA; Minimal Residual Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Lung Neoplasms; Neoplasm, Residual; Breast Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Melanoma; Neoplasms, Unknown Primary; Urogenital Neoplasms
• Other Study ID Numbers: SHERLOCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study can be shared through two types of databases: open-access or controlled-access. An open-access database is publicly accessible and contains limited clinical information and analyses of samples. A controlled-access database contains more detailed clinical information, such as relevant past medical history and the results of prior and ongoing cancer treatments, and analyses of samples, but is only accessible to researchers who sign agreements defining how data may be used. All data will be stripped of all personal identifying information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No