Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sinai Health System | OTHER |
| Women's College Hospital | OTHER |
| Jewish General Hospital | OTHER |
| IWK Health Centre |
Not provided
Not provided
Not provided
Not provided
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.
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.
CHARM1 leads into its follow-up study, CHARM2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next generation sequencing (NGS) | Genetic | NGS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Evaluation of the clinical utility of a cfDNA test for HSC patients. | Conduct qualitative interviews with healthcare providers and patients. | up to 4 years |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Individuals that do not meet the outlined inclusion criteria.
Not provided
Not provided
Not provided
The population to be studied includes:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raymond Kim, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency | Vancouver | British Columbia | V5Z 4E6 | Canada | ||
| Eastern Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009386 | Neoplastic Syndromes, Hereditary |
| D009369 | Neoplasms |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059014 | High-Throughput Nucleotide Sequencing |
| ID | Term |
|---|---|
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
| OTHER |
| British Columbia Cancer Agency | OTHER |
| Eastern Health | OTHER |
Not provided
Not provided
Not provided
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.
| St. John's |
| Newfoundland and Labrador |
| A1B 3V6 |
| Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Sinai Health System | Toronto | Ontario | M5G 1X5 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Women's College Hospital | Toronto | Ontario | M5S 1B2 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |