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NCT Number: NCT03702309

Liquid Biopsy Evaluation and Repository Development at Princess Margaret

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.

Recruiting

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Key information

Conditions

Cancer Adnexal Diseases BRCA1 Mutation BRCA2 Mutation Breast Cancer Breast Diseases Breast Neoplasms Central Nervous System Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cowden Syndrome DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hamartoma Hamartoma Syndrome, Multiple Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Leukemia Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Lynch Syndrome Male Urogenital Diseases Melanoma Meningeal Neoplasms Meningioma Metabolic Diseases Mutation Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Multiple Primary Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neoplasms, Vascular Tissue Neoplastic Syndromes, Hereditary Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nutritional and Metabolic Diseases Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location status: Recruiting

Location contact

Lillian Siu, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Celeste Yu, MSc

CONTACT

[email protected]

416-946-4501 ext. 5281

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: LIBERATE

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2018
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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