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Quantum leap in cancer detection: AI blood test could slash unnecessary biopsies

NCT ID NCT07238959

Diagnosis Sponsor: Shanghai Changzheng Hospital Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 developing a new blood test that combines quantum sensors and artificial intelligence to detect prostate cancer. Researchers will analyze DNA fragments in blood samples from 1100 men to train an AI model. The goal is to create a non-invasive, accurate diagnostic tool that could reduce the need for invasive prostate biopsies.

What this could mean

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

Active substance
Quantum detection platform analyzing cfDNA in blood
What this could lead to
If successful, this could provide a simple, non-invasive blood test to accurately diagnose prostate cancer early and avoid many unnecessary biopsies.
What could go wrong
This is an early-stage study developing and testing a new algorithm. The test may not prove accurate enough in real-world settings, and 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 1,100 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

Males aged 18-80 years with elevated PSA (\>4 ng/ml) and clinical indications for prostate biopsy.

Ages

18 to 80 years

Sex

Male participants only

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: 1. Male, aged 18-80 years; 2. PSA \> 4 ng/ml; 3. Patients meeting criteria for prostate biopsy: * fPSA/PSA \< 0.16 or PSA D \> 0.15 or PSA V \> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound/MRI) showing suspicious lesions. Exclusion Criteria: 1. Patients diagnosed with any malignant tumour within the past five years; 2. Patients who have undergone transurethral resection or enucleation of the prostate; 3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy; 4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week); 5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy; 6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders; 7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation; 8. Subjects who have undergone blood transfusion within one month prior to blood sampling; 9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year; 10. Patients deemed unsuitable for this clinical trial by the investigator; 11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia disease prostate cancer prostate neoplasm

As listed by the trial registrant

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

Benign prostate hypertrophy(BPH) Prostate cancer (diagnosis) Prostate neoplasm

How to take part

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

  1. The places running it

    7 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

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, China

  • Ningbo No. 1 Hospital

    Ningbo, Zhejiang, China

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 201209, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

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