Full Title:

Liquid Biopsy Evaluation and Repository Development at Princess Margaret

Myeloma stage or condition:

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

Study phase:

Summary/Purpose:

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

Treatments:

Study 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).

Study Type:

Observational

Study Design:

Observational Model: Cohort

Time Perspective: Prospective

Recruitment status:

Recruiting

Eligibility criteria:

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

Locations / Centres:

Princess Margaret Cancer Centre, Toronto, Ontario – Recruiting

Contacts:

Name: Celeste Yu, MSc
Phone: 416-946-4501
Extension: 5281
Email: [email protected]

Publications:

???

First posted:

2018-10-11

Actual start date:

August 3, 2017

Last updated:

2023-12-05

Estimated enrollment:

2500

Estimated completion date:

2024-07-06

Estimated primary completion date:

2024-07-06

Condition:

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

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

Accepts Healthy Volunteers

Listed location countries:

Canada

NCT number:

NCT03702309

Other study ID numbers:

LIBERATE

Has Data monitoring committee:

No

U.S. FDA-regulated product:

No

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
University Health Network, Toronto
Other

Collaborators:

???

Investigators:

Lillian Siu, MD Princess Margaret Cancer Centre

Protocol Registration and Results System:

???

Verification date:

2023-12-01