Simple blood test aims to catch cancers early in genetically prone patients
NCT ID NCT06450171
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a blood test called GRAIL Galleri that looks for signs of many different cancers at once. It is being offered to 1000 people who have a high risk of cancer due to inherited genetic conditions. The goal is to see if the test can find cancers early, when they might be easier to treat.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GRAIL Galleri blood test
- What this could lead to
- If successful, this could show that a simple blood test helps catch multiple cancers earlier in people with high genetic risk, potentially improving treatment options.
- What could go wrong
- This is an early-stage study without a control group, so it cannot prove the test saves lives. False positives or unnecessary procedures are possible risks.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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 Group 1- Cancer Predisposition Syndrome: * Age ≥ 22 for patients with TP53 germline pathogenic variants, age ≥ 35 for all other variants in cancer predisposing genes * Germline genetic testing revealed pathogenic germline variants in cancer predisposing genes (list of genes typically tested listed in pre-screening document) * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia) Inclusion Criteria Group 2 - Familial Risk: * Age ≥ 45 * Adults with family history suggestive of elevated cancer risk as defined by any the criteria below, who do not fall into Group 1: * ≥ 1 first or second degree relative on same side of the family with: * Breast, colon, gastric, endometrial, kidney cancer at or before age 50 * Triple negative breast cancer (any age) * Male breast cancer (any age) * Ovarian, pancreatic, sarcoma cancer (any age) * Neuroendocrine cancer or tumors (any age) * Metastatic prostate cancer (any age) * Multiple primary cancers (example bilateral breast cancer) * ≥ 2 first or second degree relative on same side of the family (any combination is acceptable) with breast or prostate cancer at any age Exclusion Criteria: * Individuals diagnosed with invasive malignancy within 3 years of enrollment * Have had a blood-based multi-cancer screening test within last year * Individuals with evidence of symptomatic or active cancer requiring active therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is considered acceptable and will not preclude participation) * Individuals in Group 2 whose family history of cancer was the result of a germline mutation in a cancer predisposing gene and who have tested negative for that same familial germline mutation * Individuals in Group 2 whose family history of cancer is sex-specific and who is a different sex than the proband with cancer (e.g., a male with a family history of endometrial or ovarian cancer would not be eligible) * Individuals in process of being evaluated for clinical suspicion of cancer * Individuals who have undergone a cancer risk-reducing surgery for hereditary cancer risk (e.g., mastectomy)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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