Cell-free DNA in Hereditary And High-Risk Malignancies

Hereditary Cancer Syndrome Clinical Trial

— CHARM  

Official title:

Early Detection of Cancer in High-risk Patients Through Cell-free DNA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04261972
• Other study ID #: 1655
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: October 2023

Study information

• Verified date: February 2022
• Source: University Health Network, Toronto
• Contact: Leslie Oldfield, MSc.
• Phone: 613-532-9847
• Email: charm[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Cancer Syndrome
• Neoplastic Syndromes, Hereditary
• Syndrome

Intervention

Genetic:
• Next generation sequencing (NGS)
NGS

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Eastern Health	St. John's	Newfoundland and Labrador
Canada	Sinai Health System	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario
Canada	BC Cancer Agency	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
University Health Network, Toronto	British Columbia Cancer Agency, Eastern Health, IWK Health Centre, Jewish General Hospital, Sinai Health System, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of biospecimens from 1500 HSC carriers.	Facilitate and streamline the collection, banking, and annotation of plasma samples and tumour tissue (if applicable) across Canada.	up to 4 years
Primary	Collection of clinical data from 1500 HSC carriers.	Extract clinical data for all study participants from electronic medical records. Data collection will include family history and medical history.	up to 4 years
Primary	Detection of early stage cancer in HCS patients using cfDNA.	Detect concentration of cfDNA circulating in the blood by shallow whole-genome sequencing, targeted panel analysis, and cfMeDIP.	up to 4 years
Primary	Evaluation of the clinical utility of a cfDNA test for HSC patients.	Conduct qualitative interviews with healthcare providers and patients.	up to 4 years
Primary	Evaluation of the optimal implementation of cfDNA in clinical practice.	Conduct a discrete choice experiment survey with HCS patient and providers.	up to 4 years
Primary	Evaluation of cfDNA test implementation through cost-effectiveness analysis of cfDNA versus standard of care.	Conduct economic modelling using the economic evaluation guidelines from the Canadian Agency for Drugs and Technologies in Health.	up to 4 years