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Liquid Biopsy Evaluation and Repository Development at Princess Margaret (LIBERATE)

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ClinicalTrials.gov Identifier: NCT03702309
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liquid Biopsy Evaluation and Repository Development at Princess Margaret
Actual Study Start Date : August 3, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Group/Cohort
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 Measures :
  1. Collection and annotation of biospecimens [ Time Frame: 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 :
  1. Electronic Consenting [ Time Frame: Through study completion, up to 5 years ]
    Implement an electronic informed consent process for clinical research at the Princess Margaret Cancer Centre

  2. Correlative Studies Questionnaire [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Peripheral blood samples collected serially for DNA extraction Archived tissue samples collected for DNA extraction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702309


Contacts
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Contact: Celeste Yu, MSc 416-946-4501 ext 5281 Celeste.Yu@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G2M9
Principal Investigator: Lillian Siu, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre

Additional Information:
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03702309     History of Changes
Other Study ID Numbers: LIBERATE
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Potential to share de-identified study data (including genetic data) with approved research collaborators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
High Risk
Liquid Biopsy
Circulating Tumor DNA
Blood
Molecular Profiling
Next Generation Sequencing
Solid Tumors
Hematological
Additional relevant MeSH terms:
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Kidney Neoplasms
Meningioma
Uterine Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Hamartoma Syndrome, Multiple
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Site
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms