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RecruitingNCT03702309LIBERATEUpdated Sep 25, 2026

Liquid Biopsy Evaluation and Repository Development at Princess Margaret

An observational study in Cancer, Breast Cancer and Lung Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

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

Keywords

  • High Risk
  • Liquid Biopsy
  • Circulating Tumor DNA
  • Blood
  • Molecular Profiling
  • Next Generation Sequencing
  • Solid Tumors
  • Hematological
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with solid tumors or hematological malignancy and patients identified as high-risk for cancer.

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

Exclusion Criteria:

None

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

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).

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion, up to 5 years

Secondary outcomes

  1. Electronic Consenting

    Implement an electronic informed consent process for clinical research at the Princess Margaret Cancer Centre

    Time frame: Through study completion, up to 5 years

  2. 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.

    Time frame: Through study completion, up to 5 years

06

Study locations

1 of 1 sites recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G2M9, Canada
    • Lillian Siu, MD · Principal investigator
    Recruiting
07

References and documents

Publications

  • Zhao D, Lang N, Liu T, Shelton V, Rangel-Patino J, Gong IY, Hong M, Travas A, Murad V, Alrekhais I, Metser U, Prica A, Kukreti V, Bhella S, Vijenthira A, Crump M, Kuruvilla J, Arruda A, Minden MD, Lam B, Kridel R. Risk Assessment With Ultra-Low-Pass Whole-Genome Sequencing of Cell-Free DNA for Large B-Cell Lymphoma. JCO Precis Oncol. 2025 Jul;9:e2500200. doi: 10.1200/PO-25-00200. Epub 2025 Jul 9. PubMed 40632977 ↗
  • Han K, Zou J, Zhao Z, Baskurt Z, Zheng Y, Barnes E, Croke J, Ferguson SE, Fyles A, Gien L, Gladwish A, Lecavalier-Barsoum M, Lheureux S, Lukovic J, Mackay H, Marchand EL, Metser U, Milosevic M, Taggar AS, Bratman SV, Leung E. Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer. J Clin Oncol. 2024 Feb 1;42(4):431-440. doi: 10.1200/JCO.23.00954. Epub 2023 Nov 16. PubMed 37972346 ↗
  • Sanz-Garcia E, Genta S, Chen X, Ou Q, Araujo DV, Abdul Razak AR, Hansen AR, Spreafico A, Bao H, Wu X, Siu LL, Bedard PL. Tumor-Naive Circulating Tumor DNA as an Early Response Biomarker for Patients Treated With Immunotherapy in Early Phase Clinical Trials. JCO Precis Oncol. 2023 Apr;7:e2200509. doi: 10.1200/PO.22.00509. PubMed 37027812 ↗
  • Spiliopoulou P, Janse van Rensburg HJ, Avery L, Kulasingam V, Razak A, Bedard P, Hansen A, Chruscinski A, Wang B, Kulikova M, Chen R, Speers V, Nguyen A, Lee J, Coburn B, Spreafico A, Siu LL. Longitudinal efficacy and toxicity of SARS-CoV-2 vaccination in cancer patients treated with immunotherapy. Cell Death Dis. 2023 Jan 20;14(1):49. doi: 10.1038/s41419-022-05548-4. PubMed 36670100 ↗
  • Watson GA, Sanz-Garcia E, Zhang WJ, Liu ZA, Yang SC, Wang B, Liu S, Kubli S, Berman H, Pfister T, Genta S, Spreafico A, Hansen AR, Bedard PL, Lheureux S, Abdul Razak A, Cescon D, Butler MO, Xu W, Mak TW, Siu LL, Chen E. Increase in serum choline levels predicts for improved progression-free survival (PFS) in patients with advanced cancers receiving pembrolizumab. J Immunother Cancer. 2022 Jun;10(6):e004378. doi: 10.1136/jitc-2021-004378. PubMed 35705312 ↗

Individual participant data

Plan to share: Undecided — Potential to share de-identified study data (including genetic data) with approved research collaborators.

08

Registry details

Key details

Study ID
NCT03702309
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Oct 11, 2018
Start date
Aug 3, 2017
Primary completion
Jul 6, 2027 (estimated)
Completion
Jul 6, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Celeste Yu, MSc
Contact
Celeste.Yu@uhn.ca
416-946-4501 ext. 5281
Lillian Siu, MD
principal investigator · Princess Margaret Cancer Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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