Recruiting

Liquid Biopsy

Sponsor:

University Health Network, Toronto

Code:

NCT03702309

Conditions

Cancer

Breast Cancer

Lung Cancer

Colon Cancer

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Cancer

Breast Cancer

Lung Cancer

Colon Cancer

Ovarian Cancer

Study ID

NCT03702309

Start date

Aug 3, 2017

Status verified date

Nov, 2025

Completion date

Jul 6, 2026

Anticipated

Primary completion date

Jul 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Celeste Yu, MSc

416-946-4501Celeste.Yu@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G2M9

Principal Investigator:

Lillian Siu, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-11-26.