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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

Tracking Information
First Submitted Date September 25, 2018
First Posted Date October 11, 2018
Last Update Posted Date September 25, 2019
Actual Study Start Date August 3, 2017
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03702309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 9, 2018)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Liquid Biopsy Evaluation and Repository Development at Princess Margaret
Official Title Liquid Biopsy Evaluation and Repository Development at Princess Margaret
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral blood samples collected serially for DNA extraction Archived tissue samples collected for DNA extraction
Sampling Method Non-Probability Sample
Study Population Patients with solid tumors or hematological malignancy and patients identified as high-risk for cancer.
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
Intervention Not Provided
Study Groups/Cohorts 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 9, 2018)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Celeste Yu, MSc 416-946-4501 ext 5281 Celeste.Yu@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03702309
Other Study ID Numbers LIBERATE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Potential to share de-identified study data (including genetic data) with approved research collaborators.
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Not Provided
Investigators
Principal Investigator: Lillian Siu, MD Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date September 2019