CancerLIBERATENCT03702309
Liquid Biopsy Evaluation and Repository Development at Princess Margaret
An observational study of Cancer and Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Breast Cancer, Lung Cancer
- How many people
- 2,500 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2017to 6 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with solid tumors or hematological malignancy and patients identified as high-risk for cancer.
Who may be able to join
- 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).
- Patient must be ≥ 18 years old.
- All patients must have signed and dated an informed consent form for this LIBERATE study.
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
Lillian Siu, MD
About this study
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.
- Conditions
- Cancer, Breast Cancer, Lung Cancer, Colon Cancer, Ovarian Cancer, Melanoma
- Keywords
- High Risk, Liquid Biopsy, Circulating Tumor DNA, Blood, Molecular Profiling, Next Generation Sequencing, Solid Tumors, Hematological
- Medical subject headings
- Neoplasms, Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms, Ovarian Neoplasms, Melanoma, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, up to 5 years
Secondary outcomes (2)
Electronic Consenting
Implement an electronic informed consent process for clinical research at the Princess Margaret Cancer Centre
Measured: Through study completion, up to 5 years
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.
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start3 Aug 2017
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702309
- Sponsor's protocol ID
- LIBERATE
- Acronym
- LIBERATE
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2018
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Potential to share de-identified study data (including genetic data) with approved research collaborators.
Publications
Zhao D, Lang N, Liu T, Shelton V, Rangel-Patino J, Gong IY, Hong M, Travas A, Murad V, Alrekhais I, Metser U, Prica A, Kukreti V, Bhella S, Vijenthira A, Crump M, Kuruvilla J, Arruda A, Minden MD, Lam B, Kridel R. Risk Assessment With Ultra-Low-Pass Whole-Genome Sequencing of Cell-Free DNA for Large B-Cell Lymphoma. JCO Precis Oncol. 2025 Jul;9:e2500200. doi: 10.1200/PO-25-00200. Epub 2025 Jul 9.
PubMed 40632977Han K, Zou J, Zhao Z, Baskurt Z, Zheng Y, Barnes E, Croke J, Ferguson SE, Fyles A, Gien L, Gladwish A, Lecavalier-Barsoum M, Lheureux S, Lukovic J, Mackay H, Marchand EL, Metser U, Milosevic M, Taggar AS, Bratman SV, Leung E. Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer. J Clin Oncol. 2024 Feb 1;42(4):431-440. doi: 10.1200/JCO.23.00954. Epub 2023 Nov 16.
PubMed 37972346Sanz-Garcia E, Genta S, Chen X, Ou Q, Araujo DV, Abdul Razak AR, Hansen AR, Spreafico A, Bao H, Wu X, Siu LL, Bedard PL. Tumor-Naive Circulating Tumor DNA as an Early Response Biomarker for Patients Treated With Immunotherapy in Early Phase Clinical Trials. JCO Precis Oncol. 2023 Apr;7:e2200509. doi: 10.1200/PO.22.00509.
PubMed 37027812Spiliopoulou P, Janse van Rensburg HJ, Avery L, Kulasingam V, Razak A, Bedard P, Hansen A, Chruscinski A, Wang B, Kulikova M, Chen R, Speers V, Nguyen A, Lee J, Coburn B, Spreafico A, Siu LL. Longitudinal efficacy and toxicity of SARS-CoV-2 vaccination in cancer patients treated with immunotherapy. Cell Death Dis. 2023 Jan 20;14(1):49. doi: 10.1038/s41419-022-05548-4.
PubMed 36670100Watson 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.
PubMed 35705312
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy Evaluation and Repository Development at Princess Margaret
- ClinicalTrials.gov ID
- NCT03702309
- Acronym / sponsor ID
- LIBERATE / LIBERATE
- Conditions
- Cancer, Breast Cancer, Lung Cancer, Colon Cancer, Ovarian Cancer, Melanoma
- Keywords
- High Risk, Liquid Biopsy, Circulating Tumor DNA, Blood, Molecular Profiling, Next Generation Sequencing, Solid Tumors, Hematological
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors or hematological malignancy and patients identified as high-risk for cancer.
Key inclusion criteria (4 listed)
- 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).
- Patient must be ≥ 18 years old.
- All patients must have signed and dated an informed consent form for this LIBERATE study.
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Electronic Consenting
Time frame: Through study completion, up to 5 years
Correlative Studies Questionnaire
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 40632977Zhao D, Lang N, Liu T, Shelton V, Rangel-Patino J, Gong IY, Hong M, Travas A, Murad V, Alrekhais I, Metser U, Prica A, Kukreti V, Bhella S, Vijenthira A, Crump M, Kuruvilla J, Arruda A, Minden MD, Lam B, Kridel R. Risk Assessment With Ultra-Low-Pass Whole-Genome Sequencing of Cell-Free DNA for Large B-Cell Lymphoma. JCO Precis Oncol. 2025 Jul;9:e2500200. doi: 10.1200/PO-25-00200. Epub 2025 Jul 9.
- Derived from this study: PubMed 37972346Han K, Zou J, Zhao Z, Baskurt Z, Zheng Y, Barnes E, Croke J, Ferguson SE, Fyles A, Gien L, Gladwish A, Lecavalier-Barsoum M, Lheureux S, Lukovic J, Mackay H, Marchand EL, Metser U, Milosevic M, Taggar AS, Bratman SV, Leung E. Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer. J Clin Oncol. 2024 Feb 1;42(4):431-440. doi: 10.1200/JCO.23.00954. Epub 2023 Nov 16.
- Derived from this study: PubMed 37027812Sanz-Garcia E, Genta S, Chen X, Ou Q, Araujo DV, Abdul Razak AR, Hansen AR, Spreafico A, Bao H, Wu X, Siu LL, Bedard PL. Tumor-Naive Circulating Tumor DNA as an Early Response Biomarker for Patients Treated With Immunotherapy in Early Phase Clinical Trials. JCO Precis Oncol. 2023 Apr;7:e2200509. doi: 10.1200/PO.22.00509.
- Derived from this study: PubMed 36670100Spiliopoulou P, Janse van Rensburg HJ, Avery L, Kulasingam V, Razak A, Bedard P, Hansen A, Chruscinski A, Wang B, Kulikova M, Chen R, Speers V, Nguyen A, Lee J, Coburn B, Spreafico A, Siu LL. Longitudinal efficacy and toxicity of SARS-CoV-2 vaccination in cancer patients treated with immunotherapy. Cell Death Dis. 2023 Jan 20;14(1):49. doi: 10.1038/s41419-022-05548-4.
- Derived from this study: PubMed 35705312Watson 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.
- Princess Margaret Cancer Genomics ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Potential to share de-identified study data (including genetic data) with approved research collaborators.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lillian Siu, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celeste Yu, MSc (416-946-4501 ext. 5281, Celeste.Yu@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection and annotation of biospecimens (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702309, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.