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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
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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.
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.
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Early stage or locally advanced disease that is planned for or have undergone curative treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Vuong | Contact | 437-676-6598 | Gilgan.Centre@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lillian Siu, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Scott Bratman, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D014565 | Urogenital Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009382 | Neoplasms, Unknown Primary |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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