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Blood test may spot hidden cancers years early

NCT ID NCT04405557

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing whether a blood test that looks for tumor DNA (ctDNA) can detect six types of cancer early in people at high risk. About 757 participants aged 45 and older with certain risk factors are being monitored. The goal is to see how accurate the test is and how much time it gives before a standard diagnosis.

What this could mean

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

What this could lead to
If successful, this could lead to a simple blood test that catches several cancers earlier, when they may be easier to treat.
What could go wrong
This is an observational study, not a treatment trial. It only measures how well ctDNA detects cancer; it does not prove that early detection improves outcomes. Results may not apply to all populations.

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 757 people

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

Started

Nov 2019

Expected to finish

Dec 2026

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

People with positive tumor protein marker or cancer screening.

Ages

45 years and older

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: 1. Patients aged at or over 45 years old. 2. Patients who with one or more of the following situations: 1. In AFP (\>20UG/L), CA125 (\>70U/ml), CEA (\>7ng/ml) and CA199 (\>60U/ml), more than one item was abnormal for two consecutive times within one month. 2. Patients with viral hepatitis (Hepatitis B / C surface antigen positive with liver function damage. 3. Patients with liver nodules detected by ultrasound and hemangioma excluded. 4. Patients with compensated cirrhosis. 5. CA125\>35U/ml and HE4 was abnormal (the reference value of HE4 in premenopausal and postmenopausal women was 68.96 pmol/L and 114.90 pmol/L respectively). 6. Patients with ovarian masses found by ultrasonography (premenopausal \> 5cm, postmenopausal \> 3.5cm). 7. Patients with pancreatic space-occupying found by ultrasonography. 8. Patients with BI-RADS grade 4 or above by ultrasound or mammography. 9. CA125\>35U/ml and BI-RADS above grade 3 by ultrasound or mammography. 10. CA153\>25U/ml and BI-RADS above grade 3 by ultrasound or mammography. 11. Family genetic history of breast cancer and ovarian cancer, and BI-RADS above grade 3 by ultrasound or mammography. 12. Patients with a positive fecal occult blood test and haemorrhoids excluded 13. Patients with a positive fecal occult blood test and positive CEA 14. More than 2 items were abnormal in PGI, PGR and G-17 (criteria: PGI≤70 UG/L, PGR≤7.0, G-17≤1 pmol/L or G-17≥15 pmol/L). 3. Ability to collect specimens from each time point and provide corresponding clinical information. 4. Understand the research plan and voluntarily participate in the study, sign the informed consent form. Exclusion Criteria: 1. Patients with previous or present cancer. 2. Patients with serious diseases, especially those with a survival period of less than 3 years. 3. Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.). 4. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 5. Women who are pregnant or preparing for pregnancy. 6. Patients who voluntarily withdraw for any reason. 7. Patients who cannot complete the research plan

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As listed by the trial registrant

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

Contacts and locations

Locations

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121001, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

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