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One blood draw, many cancers: AI model aims to spot tumors early

NCT ID NCT06217900

Diagnosis Sponsor: Shanghai Weihe Medical Laboratory Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are developing a blood test that uses DNA methylation patterns and machine learning to detect multiple types of cancer at an early stage. The PROFOUND study collects blood samples from people newly diagnosed with cancer and from people without a confirmed cancer diagnosis, ages 40 to 74. By comparing the two groups, the team aims to build and test a model that can tell cancer from non-cancer and identify where in the body the cancer started.

What this could mean

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

Active substance
a blood test that uses DNA methylation patterns and machine learning to detect multiple cancers
What this could lead to
If it works, this could give doctors a single blood test that flags several cancers at once before symptoms appear, when treatment tends to work better.
What could go wrong
The test may miss cancers or flag people who do not have cancer, leading to unnecessary follow-up tests and anxiety. This study builds and checks the model, so real-world accuracy in a general population remains uncertain.

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 16,666 people

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

Started

Dec 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Confirmed cancers or individuals without confirmed cancer will be invited to participate in this case-control study by a designated consenting professional.

Ages

40 to 74 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for Case Arm Participants: * 40-74 years old * Clinically and/or pathologically diagnosed cancer * No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Case Arm Participants: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to screen * Recipients of therapy in past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide * Unsuitable for this trial determined by the researchers Inclusion Criteria for Control Arm Participants: * 40-74 years old * Without confirmed cancer diagnosis * Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Control Arm Participants: * Pregnancy or lactating women * Known prior or current diagnosis of other types of malignancies comorbidities * Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) within 14 days prior to screen * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 30 days prior to screen * Recipients of therapy in the past 14 days prior to screen, including oral or IV glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide * Unsuitable for this trial determined by the researchers

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

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

Cancer

How to take part

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

  1. The places running it

    1 site. 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

  • Cancer Hospital, Chinese Academy of Medical Sciences

    ACTIVE_NOT_RECRUITING

    Beijing, China

  • Liaoning Tumor Hospital & Institute

    ACTIVE_NOT_RECRUITING

    Shenyang, China

  • Peking University Cancer Hospital and Institute

    ACTIVE_NOT_RECRUITING

    Beijing, Beijing Municipality, 100083, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • The First Affiliated Hospital, Sun Yat-sen University

    ACTIVE_NOT_RECRUITING

    Guangzhou, China

  • The First Hospital of Jilin University

    ACTIVE_NOT_RECRUITING

    Changchun, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    ACTIVE_NOT_RECRUITING

    Hangzhou, China

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    ACTIVE_NOT_RECRUITING

    Guangzhou, China

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