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RECRUITING
NCT06726642

CfDNA in Hereditary And High-risk Malignancies 2

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

The goal of this study is to understand the performance of an experimental blood test that aims to detect early tumors in patients with hereditary cancer syndromes. 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 compare cancer detection rates between those receiving the new blood test and those receiving standard care, assess if the test leads to earlier cancer diagnosis, and evaluate its impact on patient outcomes. The study will also use questionnaires and interviews to understand how patients feel about the blood test, its incorporation into routine medical care, and perceptions of the medical value of test results. This research could lead to more effective and less invasive cancer screening for high-risk individuals.

Official title: CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection

Key Details

Gender

All

Age Range

Any - 90 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2024-04-19

Completion Date

2031-12

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Cell-free DNA analysis

Analysis of cell-free DNA in blood plasma will involve targeted sequencing of key cancer-related genes, cell-free methylated DNA immunoprecipitation and high-throughput sequencing (cfMeDIP-seq), and shallow whole genome sequencing (sWGS).

Locations (8)

BC Cancer Agency

Vancouver, British Columbia, Canada

Eastern Health

St. John's, Newfoundland and Labrador, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Sinai Health System

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Women's College Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada