Can we spot cancer before it starts? a massive study aims to find out
NCT ID NCT05463796
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This study is building a large collection of blood, saliva, urine, stool, and tissue samples from people who are at increased risk of cancer, including those with genetic predispositions, survivors of childhood or adult cancer, or those with precancerous conditions. The goal is to identify early changes and risk factors that could predict cancer development. By tracking participants over time, researchers hope to find new markers for early detection and ways to intercept cancer before it becomes life-threatening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Collection of biological samples (blood, saliva, urine, stool, tissue) for research
- What this could lead to
- If successful, this could lead to better ways to predict who will develop cancer and new strategies to stop it before it becomes serious.
- What could go wrong
- This is an observational study, so it won't directly test a treatment. It may take years to find useful markers, and the findings might not apply to everyone.
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
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About 5,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Mar 2031
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.
Who is studied
Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type Hereditary risk for cancer, Exposed High Risk, Precursor Lesions, FAMILY MEMBERS
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type): 1-Hereditary risk for cancer including * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing) * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia) * Hereditary Cancer Prediction Model-based elevated cancer risk * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc. * Exposed High Risk including * Childhood cancer survivors with treatment exposures associated with increased risk of cancer * Adult cancer survivors with treatment exposures associated with increased risk of cancer * Documented high level exposure to group 1 IARC carcinogens * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \>50, Smoking history of \>15 pack years, First-degree relative history of lung cancer or COPD * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis * Precursor Lesions including * Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ, * Lung: Adenomatous hyperplasia * H\&N: high-risk oral precancerous diseases * Skin: Class II melanocytic lesions. Squamous dysplasia * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas * Thoracic: Lung nodules detected on screening CT that prompt further follow-up * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others. * FAMILY MEMBERS or healthy individuals Exclusion Criteria: There are no exclusion criteria for the study. Note: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02115, United States
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