Blood test for early cancer detection in hereditary cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a new blood test that detects early tumors in patients with hereditary cancer syndromes. It will compare cancer detection rates between those using the new test and those receiving standard care, while also assessing the impact on cancer stage, patient outcomes, and quality of life. The study involves a multi-center approach across Canada, utilizing questionnaires and interviews to gather patient feedback on the test's integration into routine care. The goal is to enhance cancer screening methods for high-risk individuals through less invasive techniques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer.
* Patients undergoing investigations for a clinical suspicion of cancer.
* Patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).

Where it's running

• BC Cancer Agency
  Vancouver, British Columbia, Canada Recruiting
• Newfoundland and Labrador Health Services (previously Eastern Health)
  St. John's, Newfoundland and Labrador, Canada Recruiting
• IWK Health Centre
  Halifax, Nova Scotia, Canada Recruiting
• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting
• Sinai Health System
  Toronto, Ontario, Canada Recruiting
• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Raymond Kim, MD — Princess Margaret Cancer Centre
• Study coordinator: Julia Sobotka, MSc
• Email: charm@uhn.ca
• Phone: 416-409-1387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EHR-based approach to boost HBOC genetic testing in at-risk women

  A new EHR tool-based program tests whether computer prompts and real patient resources can help more women with family histories of breast or ovarian cancer get HBOC genetic testing.

  Recruiting Columbia University · New York, New York · NCT07876349

• Hereditary cancer screening offered during obstetrical carrier screening

  This project will test offering hereditary cancer genetic testing to pregnant and preconception patients who are already getting obstetrical carrier screening to see if they want it and can complete testing alongside routine prenatal care.

  Recruiting Columbia University · New York, New York · NCT07195071

• Understanding the immune response in Lynch syndrome patients

  This study is trying to see if certain antibodies in the immune system can help spot early signs of cancer in people with Lynch syndrome.

  Recruiting at 5 sites San Raffaele University · Monrovia, California and 4 other locations · NCT06708429

• Bringing genetic testing for hereditary breast and colon cancer into community health centers

  This project tests whether a mainstream genetic testing approach versus an enhanced usual-care approach increases genetic testing among adults at risk for hereditary breast or colon cancer seen in urban community health centers.

  Recruiting University of Illinois Chicago · Chicago, Illinois · NCT05664867

• Using a chatbot to improve genetic risk assessment for hereditary cancer

  This study is testing if a chatbot can help more patients at risk for hereditary cancer get recommended for genetic testing compared to regular care in a gynecology clinic.

  Recruiting at 4 sites Weill Medical College of Cornell University · Brooklyn, New York and 3 other locations · NCT05562778

• Understanding Li-Fraumeni Syndrome and TP53 Variants

  This study is trying to understand cancer risks in people with Li-Fraumeni Syndrome or TP53 gene changes to help improve prevention and treatment options.

  Recruiting at 3 sites Dana-Farber Cancer Institute · Boston, Massachusetts and 2 other locations · NCT04541654

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.