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Simple blood test could spot cancer earlier in High-Risk individuals

NCT ID NCT06726642

Diagnosis Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new blood test that looks for DNA fragments from tumors in people with hereditary cancer syndromes like Lynch syndrome or BRCA mutations. The goal is to see if the test can find cancers earlier than standard screening methods. Researchers will compare cancer detection rates between those getting the blood test and those receiving usual care, and also ask participants about their experience. If accurate, this test could offer a simpler, less invasive way to monitor high-risk patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cell-free DNA blood test
What this could lead to
If successful, this blood test could provide a less invasive way to detect cancer earlier in people with inherited cancer risks, potentially improving survival.
What could go wrong
This is an early-stage study testing the test's accuracy. It may not detect all cancers or could give false results. The test is not yet proven for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The population to be studied includes: Any individual that underwent clinical genetic testing for hereditary breast and ovarian cancer syndrome, Lynch Syndrome, Neurofibromatosis Type 1, Li-Fraumeni Syndrome or Hereditary Diffuse Gastric Cancer, and was found to carry a detectable variant that is likely pathogenic or pathogenic.

Ages

Up to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis gastric neoplasm hereditary breast ovarian cancer syndrome hereditary diffuse gastric adenocarcinoma hereditary neoplastic syndrome Li-Fraumeni syndrome Lynch syndrome neurofibromatosis type 1 PALB2-related cancer predisposition

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary cancer syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BC Cancer Agency

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Eastern Health

    NOT_YET_RECRUITING

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • IWK Health Centre

    NOT_YET_RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Jewish General Hospital

    NOT_YET_RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Sinai Health System

    RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • The Hospital for Sick Children

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1E8, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Women's College Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5S 1B2, Canada

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