Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Study Overview
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Brief Summary
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The objective of this protocol is to develop an institution-wide liquid biopsy protocol that will establish a common process for collecting blood and corresponding archived tumor specimens for future research studies at the University Health Network's Princess Margaret Cancer Centre. Circulating cell-free nucleic acids (cfNA), including cell-free DNA (cfDNA) and cell-free RNA (cfRNA), are non-invasive, real-time biomarkers that can provide diagnostic and prognostic information before cancer diagnosis, during cancer treatment, and at disease progression. Cancer research scientists and clinicians at the Princess Margaret are interested in incorporating the collection of peripheral blood samples (liquid biopsies) into research protocols as a means of non-invasively assessing tumor progression and response to treatment at multiple time points during a patient's course of disease.

Official Title
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Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Conditions
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Cancer, Breast Cancer, Lung Cancer, Colon Cancer, Ovarian Cancer, Melanoma, Lymphoma, Leukemia, Mutation, Lynch Syndrome, Cowden Syndrome, BRCA1 Mutation, BRCA2 Mutation, Uterine Cancer, Kidney Cancer, Head and Neck Cancer, Meningioma, Myeloma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with either histological confirmation of a solid tumor or hematological malignancy, OR patients identified as high-risk for cancer (based on identified aberration in cancer predisposition gene or on hormonal and/or family history without known aberration). Patient must be ≥ 18 years old. All patients must have signed and dated an informed consent form for this LIBERATE study. If patients are being co-consented for a separate primary research study listed in Appendix I, they must fulfill the eligibility criteria for that separate primary research study. If there is a discrepancy in the eligibility criteria between protocols, the separate primary research study's criteria take precedence. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LIBERATE<br>Patients with either histological confirmation of a solid tumor or hematological malignancy, or patients identified as high-risk for cancer (based on identified aberration in cancer predisposition gene or on hormonal and/or family history without known aberration). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection and annotation of biospecimens | Facilitate and streamline the collection, banking, and annotation of biospecimens (especially liquid biopsy specimens and optionally corresponding archived tumor specimens) for research studies across the University Health Network institution | Through study completion, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronic Consenting | Implement an electronic informed consent process for clinical research at the Princess Margaret Cancer Centre | Through study completion, up to 5 years | 
| Correlative Studies Questionnaire | Collect observational/epidemiological data using a Correlative Studies Questionnaire for clinical annotation of specimens and future research use. Data collected involves demographics such as family history, medical history, smoking history, and lifestyle. | Through study completion, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Risk, Liquid Biopsy, Circulating Tumor DNA, Blood, Molecular Profiling, Next Generation Sequencing, Solid Tumors, Hematological