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Cell-free DNA in Hereditary And High-Risk Malignancies (CHARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261972
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 15, 2022
Sponsor:
Collaborators:
Sinai Health System
Women's College Hospital
British Columbia Cancer Agency
Jewish General Hospital
IWK Health Centre
Eastern Health
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
The goal of this study is to develop an effective, sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes (HCS). If this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. The study will also use questionnaires and interviews to understand how patients feel about incorporating these tests into routine medical care, and the perceptions of the medical value of test results.

Condition or disease Intervention/treatment
Hereditary Cancer Syndrome Genetic: Next generation sequencing (NGS)

Detailed Description:
The objective of this protocol is to develop a method to detect early signs of cancer in 'previvors' (people with HCS that do not yet have a cancer diagnosis). This will enable prediction of cancer onset so that patients and their doctors can make decisions to treat or prevent the cancers. HCS patients will be recruited from across Canada to provide blood samples before and after cancer diagnosis. In parallel, there will be development of a circulating tumour DNA (ctDNA) -based test to detect early stage cancer and evaluation on the cost-effectiveness and feasibility of integrating such screening protocols into routine clinical care. In concert, consultation with patients and health care providers will occur to create recommendations for use within clinical care.
Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Cancer in High-risk Patients Through Cell-free DNA
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
CHARM
Patients identified with hereditary breast and ovarian cancer syndrome (germline BRCA1 or BRCA2 carrier) or Lynch syndrome (germline variant in EPCAM, MLH1, MSH2, MSH6, or PMS2).
 Genetic: Next generation sequencing (NGS)
NGS


Outcome Measures
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Primary Outcome Measures :
  1. Collection of biospecimens from 1500 HSC carriers. [ Time Frame: up to 4 years ]
    Facilitate and streamline the collection, banking, and annotation of plasma samples and tumour tissue (if applicable) across Canada.

  2. Collection of clinical data from 1500 HSC carriers. [ Time Frame: up to 4 years ]
    Extract clinical data for all study participants from electronic medical records. Data collection will include family history and medical history.

  3. Detection of early stage cancer in HCS patients using cfDNA. [ Time Frame: up to 4 years ]
    Detect concentration of cfDNA circulating in the blood by shallow whole-genome sequencing, targeted panel analysis, and cfMeDIP.

  4. Evaluation of the clinical utility of a cfDNA test for HSC patients. [ Time Frame: up to 4 years ]
    Conduct qualitative interviews with healthcare providers and patients.

  5. Evaluation of the optimal implementation of cfDNA in clinical practice. [ Time Frame: up to 4 years ]
    Conduct a discrete choice experiment survey with HCS patient and providers.

  6. Evaluation of cfDNA test implementation through cost-effectiveness analysis of cfDNA versus standard of care. [ Time Frame: up to 4 years ]
    Conduct economic modelling using the economic evaluation guidelines from the Canadian Agency for Drugs and Technologies in Health.


Biospecimen Retention:   Samples With DNA
Longitudinal blood plasma collected annually on patients. Archived formalin-fixed paraffin-embedded tissue or fresh frozen tissue from a biopsy or surgery is collected when applicable.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The population to be studied includes:

  1. Any individual that underwent clinical genetic testing for hereditary breast and ovarian cancer syndrome or Lynch Syndrome and was found to carry a detectable variant that is likely pathogenic or pathogenic.
  2. Any individual with a suspected cancer predisposition that has not yet received genetic testing.
  3. Any individual who received negative genetic test results but has a strong personal or family history of cancer.
Criteria

Inclusion Criteria:

  1. Individual with any known or suspected hereditary cancer predisposition (i.e. individuals with an identified pathogenic or likely pathogenic variant in a cancer predisposition gene and/or a family history of cancer without an identified gene mutation) at any stage in their cancer journey (ie: cancer survivor, unaffected with cancer, current cancer patient).
  2. Individual must be greater than 18 years of age
  3. Individual must speak English or French to participate in the qualitative interview and/or survey

Exclusion Criteria:

1. Individuals that do not meet the outlined inclusion criteria.

Contacts and Locations
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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): NCT04261972


Contacts
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Contact: Leslie Oldfield, MSc. 613-532-9847 charm@uhnresearch.ca

Locations
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Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Intan Schrader, MD    604-877-6000 ext 672198    ischrader@bccancer.bc.ca   
Contact: Sara Singh       sara.singh@bccancer.bc.ca   
Principal Investigator: Intan Schrader, MD         
Canada, Newfoundland and Labrador
Eastern Health Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Lesa Dawson    709-749-9686    lmdawson@mun.ca   
Contact: Stacy Whittle       stacy.whittle@easternhealth.ca   
Principal Investigator: Lesa Dawson, MD         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Lynette Penney       lynette.penney@iwk.nshealth.ca   
Principal Investigator: Lynette Penney, MD         
Canada, Ontario
Sinai Health System Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Raymond Kim, MD    416-586-4800 ext 4220    raymond.kim@uhn.ca   
Principal Investigator: Raymond Kim, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Raymond Kim, MD    416-586-4800 ext 4220    raymond.kim@uhn.ca   
Contact: Leslie Oldfield, MSc    613-532-9847    leslie.oldfield@uhnresearch.ca   
Principal Investigator: Raymond Kim, MD         
Women's College Hospital Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Gabby Ene         
Contact    (416)-946-4501 ext 3969    gabrielle.ene@uhnresearch.ca   
Principal Investigator: Marcus Bernardini, MD         
Principal Investigator: Michelle Jacobson, MD         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: William Foulkes       william.foulkes@mcgill.ca   
Contact: Mark Basik       mark.basik@mcgill.ca   
Principal Investigator: William Foulkes, MD         
Principal Investigator: Mark Basik, MD         
Sponsors and Collaborators
University Health Network, Toronto
Sinai Health System
Women's College Hospital
British Columbia Cancer Agency
Jewish General Hospital
IWK Health Centre
Eastern Health
Investigators
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Principal Investigator: Raymond Kim, MD Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04261972    
Other Study ID Numbers: 1655
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Circulating tumour DNA
Cell-free DNA (cfDNA)
Hereditary cancer syndrome
Cancer
BRCA1
 Lynch syndrome
Hereditary breast and ovarian cancer
Liquid biopsies
BRCA2
Additional relevant MeSH terms:
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Neoplastic Syndromes, Hereditary
Syndrome
Disease
 Pathologic Processes
Neoplasms
Genetic Diseases, Inborn