Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Recruiting

• Conditions: Colon Cancer; Uterine Cancer; Lung Cancer; BRCA1 Mutation; BRCA2 Mutation; Kidney Cancer; Leukemia; Mutation; Cowden Syndrome; Breast Cancer

• Registration Number: NCT03702309
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-03
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-07-06
• Study Completion: 2025-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection and annotation of biospecimens	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 Outcome Measures

Name	Time	Method
Electronic Consenting	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	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.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada