Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2022

Arms, Groups and Cohorts

  • LIBERATE
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Collection and annotation of biospecimens
    • Time Frame: Through study completion, up to 5 years
    • 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

Secondary Measures

  • Electronic Consenting
    • Time Frame: Through study completion, up to 5 years
    • Implement an electronic informed consent process for clinical research at the Princess Margaret Cancer Centre
  • Correlative Studies Questionnaire
    • Time Frame: Through study completion, up to 5 years
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. 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). 2. Patient must be ≥ 18 years old. 3. All patients must have signed and dated an informed consent form for this LIBERATE study. 4. 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lillian Siu, MD, Principal Investigator, Princess Margaret Cancer Centre
  • Overall Contact(s)
    • Celeste Yu, MSc, 416-946-4501, Celeste.Yu@uhn.ca

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