NCT06726642Recruiting
CfDNA in Hereditary And High-risk Malignancies 2
CfDNA in Hereditary And High-risk Malignancies (CHARM) 2: Evaluating the Performance of a cfDNA Blood Test for Early Cancer Detection
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 8 Nov 2024
- Start date
- 19 Apr 2024
- Primary completion date
- Dec 2029
- Lead sponsor
- University Health Network, Toronto
- NCT number
- NCT06726642
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 19 Apr 2024 to the primary completion date, Dec 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer.
Other illness
- Patients must not have a personal history of cancer diagnosed and treated within 3 years prior to the expected first sample collection date for this study. If a patient has a personal history of cancer, treatment must have been completed successfully at least 3 years prior to first study sample collection.
- Patients undergoing investigations for a clinical suspicion of cancer.
Other
- Patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).
Who the study is looking for
- Patients with a confirmed diagnosis of hereditary breast and ovarian cancer (HBOC), Lynch Syndrome (LS), Neurofibromatosis type I (NF1), Li-Fraumeni Syndrome (LFS), PALB2, and Hereditary Diffuse Gastric Cancer (HDGC), (i.e., patients with an identified pathogenic variant in the respective cancer predisposition gene, or patients with uninformative genetic testing but with a family history suggestive of the cancer predisposition syndrome).
- Patients must be receiving standard-of-care clinical assessment for cancer by a managing physician under a provincial screening program or cancer surveillance protocol.
- All patients must have signed and dated an informed consent form for this study.
Age in the registry: - to 90 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Newfoundland and Labrador Health Services (previously Eastern Health) Coordinator of this site? Confirm its status | St. John's | Canada | Recruiting |
| Sinai Health System Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| BC Cancer Agency Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.