Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Breast Cancer Clinical Trial

— LIBERATE  

Official title:

Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03702309
• Other study ID #: LIBERATE
• Status: Recruiting
• Start date: August 3, 2017
• Est. completion date: July 6, 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Celeste Yu, MSc
• Phone: 416-946-4501
• Email: Celeste.Yu[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: July 6, 2024
• Est. primary completion date: July 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Mutation
• BRCA2 Mutation
• Breast Cancer
• Cancer
• Colon Cancer
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Cowden Syndrome
• Hamartoma Syndrome, Multiple
• Head and Neck Cancer
• Kidney Cancer
• Leukemia
• Lung Cancer
• Lymphoma
• Lynch Syndrome
• Melanoma
• Meningioma
• Mutation
• Myeloma
• Ovarian Cancer
• Syndrome
• Uterine Cancer
• Uterine Neoplasms

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion, up to 5 years
Secondary	Electronic Consenting	Implement an electronic informed consent process for clinical research at the Princess Margaret Cancer Centre	Through study completion, up to 5 years
Secondary	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.	Through study completion, up to 5 years

External Links

•   Princess Margaret Cancer Genomics Program