Clinical trial NCT03702309: Liquid Biopsy Evaluation and Repository Development at Princess Margaret
Official title: Liquid Biopsy Evaluation and Repository Development at Princess Margaret
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: High Risk
Liquid Biopsy
Circulating Tumor DNA
Blood
Molecular Profiling
Next Generation Sequencing
Solid Tumors
Hematological
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid tumors or hematological malignancy and patients identified as high-risk for cancer.

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.


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

Primary outcomes:
measure: Collection and annotation of biospecimens
timeFrame: Through study completion, up to 5 years
Secondary outcomes:
measure: Electronic Consenting
timeFrame: Through study completion, up to 5 years
measure: Correlative Studies Questionnaire
timeFrame: Through study completion, up to 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Lillian Siu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watson GA, Sanz-Garcia E, Zhang WJ, Liu ZA, Yang SC, Wang B, Liu S, Kubli S, Berman H, Pfister T, Genta S, Spreafico A, Hansen AR, Bedard PL, Lheureux S, Abdul Razak A, Cescon D, Butler MO, Xu W, Mak TW, Siu LL, Chen E. Increase in serum choline levels predicts for improved progression-free survival (PFS) in patients with advanced cancers receiving pembrolizumab. J Immunother Cancer. 2022 Jun;10(6):e004378. doi: 10.1136/jitc-2021-004378.