Breast CancerSHERLOCKNCT07524114
Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)
An observational study of Breast Cancer and Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Melanoma
- How many people
- 7,000 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2026to 31 Mar 2031
- 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 or locally advanced disease that is planned for or have undergone curative treatment.
Who may be able to join
- 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.
- 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.
- Patient must be ≥ 18 years old.
- All patients must have signed and dated an informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Kimberly Vuong, 437-676-6598
Lillian Siu, MD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Lung Cancer, Melanoma, Gynecologic Cancer, Genitourinary Cancer, Pancreatobiliary Cancer
- Keywords
- Minimal Residual Disease, Liquid Biopsy, Circulating Tumor DNA
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Melanoma, Urogenital Neoplasms, Gastrointestinal Neoplasms, Head and Neck Neoplasms, Neoplasms, Unknown Primary, Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect, annotate, and analyze biospecimens for the detection of MRD
Measured: 5 years
To determine the prevalence of MRD over time across tumor types
Measured: 5 Years
Secondary outcomes (1)
Create a long-term collection of blood test data and medical information to track how cancer-related DNA changes over time.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Mar 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Cancer CentreScott Bratman, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524114
- Sponsor's protocol ID
- SHERLOCK
- Acronym
- SHERLOCK
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)
- ClinicalTrials.gov ID
- NCT07524114
- Acronym / sponsor ID
- SHERLOCK / SHERLOCK
- Conditions
- Breast Cancer, Lung Cancer, Melanoma, Gynecologic Cancer, Genitourinary Cancer, Pancreatobiliary Cancer
- Keywords
- Minimal Residual Disease, Liquid Biopsy, Circulating Tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
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 design
- Observational model
- Cohort
- 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 or locally advanced disease that is planned for or have undergone curative treatment.
Key inclusion criteria (4 listed)
- 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.
- 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.
- Patient must be ≥ 18 years old.
- All patients must have signed and dated an informed consent form.
Key exclusion criteria (1 listed)
- 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.
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
To collect, annotate, and analyze biospecimens for the detection of MRD
Time frame: 5 years
To determine the prevalence of MRD over time across tumor types
Time frame: 5 Years
1 secondary outcome
Create a long-term collection of blood test data and medical information to track how cancer-related DNA changes over time.
Time frame: 5 years
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 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Lillian Siu, MD principal investigator
Princess Margaret Cancer Centre
Scott Bratman, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by University Health Network, Toronto at 1 site 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 4 inclusion and 1 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Kimberly Vuong (437-676-6598, Gilgan.Centre@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect, annotate, and analyze biospecimens for the detection of MRD (time frame: 5 years). 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?
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 21 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.