Benign Prostate Hypertrophy(BPH)NCT07238959
Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer
An observational study of Benign Prostate Hypertrophy(BPH) and Prostate Cancer (Diagnosis), run by Shanghai Changzheng Hospital at 7 sites in China.
Trial summary
This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH), Prostate Cancer (Diagnosis), Prostate Neoplasm
- What is being tested?
- Quantum Detection
- How many people
- 1,100 participants
- Where
- 7 sitesChina
- Study dates
- Dec 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males aged 18-80 years with elevated PSA (>4 ng/ml) and clinical indications for prostate biopsy.
Who may be able to join
- Male, aged 18-80 years;
- PSA > 4 ng/ml;
- 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.
Who cannot join
- Patients diagnosed with any malignant tumour within the past five years;
- Patients who have undergone transurethral resection or enucleation of the prostate;
- Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;
- Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);
- Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy;
- 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;
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- Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;
- Subjects who have undergone blood transfusion within one month prior to blood sampling;
- Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;
- Patients deemed unsuitable for this clinical trial by the investigator;
- Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Duocai Li contact
7 sites in 1 country
China7 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Fei Liu, 86010-87787170, liufei_2359@163.com
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Lu Yang, 86028-855422114, wycleflue@scu.edu.cn
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Di Gu, 86020-83062114, sveong@163.com
Kaoqing Peng, pengkaoqing@163.com
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Ningbo No. 1 Hospital
Ningbo, Zhejiang
Junhui Jiang, 860574-87085588, 13967810448@126.com
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 201209
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Yuhua Huang, 860512-65223637, sdfyy_hyh@163.com
About this study
This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.
- Being tested
- Quantum Detection
- Keywords
- Early diagnosis, cfDNA
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantum DetectionDiagnostic test
This cohort will utilize archived plasma samples from a historical patient population with confirmed diagnoses (prostate cancer vs. controls). The objective is model development. The intervention involves analyzing these stored samples using the quantum sensing platform to extract multi-modal cfDNA features (e.g., fragmentomics, methylation). This data is then used to train and optimize the initial AI diagnostic algorithm, establishing the core model before prospective validation.
Quantum DetectionDiagnostic test
This cohort will prospectively enroll new patients with suspected prostate cancer from the same institution as testing cohort. The objective is initial model validation. The intervention entails collecting pre-biopsy blood samples from these participants. The cfDNA from these fresh samples is analyzed using the locked model from the training phase. The model's predictions are then compared against the gold-standard prostate biopsy results to assess initial diagnostic performance.
Quantum DetectionDiagnostic test
This cohort will prospectively recruit patients from multiple independent clinical centers. The objective is to test the model's generalizability. The intervention involves standardized blood collection across all external sites, with samples sent to a central lab for blinded cfDNA analysis using the finalized, locked-down model.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Testing Cohort | Not described Receives: Diagnostic Test: Quantum Detection | |
| Prospective Internal Validation Cohort | Not described Receives: Diagnostic Test: Quantum Detection | |
| Prospective external Validation Cohort | Not described Receives: Diagnostic Test: Quantum Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic curve (AUC-ROC) for the predictive model in the general population for prostate cancer.
Measured: Through primary completion which may take 12 months.
Sensitivity of the predictive model in detecting prostate cancer within the general population.
Measured: Through primary completion which may take 12 months.
Specificity of the predictive model in detecting prostate cancer within the general population.
Measured: Through primary completion which may take 12 months.
Secondary outcomes (3)
Area under the ROC curve for the predictive model in identifying prostate cancer within the PSA grey zone cohort.
Measured: Through primary completion which may take 12 months.
Sensitivity of the predictive model in identifying prostate cancer within the PSA grey zone cohort.
Measured: Through primary completion which may take 12 months.
The specificity of the predictive model in identifying prostate cancer among individuals in the PSA grey zone.
Measured: Through primary completion which may take 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Ningbo University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Soochow University
- Responsible party
- Principal investigator, Ren Shancheng, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238959
- Sponsor's protocol ID
- CAPS
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07238959
- Acronym / sponsor ID
- CAPS
- Keywords
- Early diagnosis, cfDNA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital of Ningbo University, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Soochow University
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective Testing Cohort | – | Diagnostic Test: Quantum Detection |
| Prospective Internal Validation Cohort | – | Diagnostic Test: Quantum Detection |
| Prospective external Validation Cohort | – | Diagnostic Test: Quantum Detection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males aged 18-80 years with elevated PSA (>4 ng/ml) and clinical indications for prostate biopsy.
Key inclusion criteria (4 listed)
- Male, aged 18-80 years;
- PSA > 4 ng/ml;
- Patients meeting criteria for prostate biopsy:
Key exclusion criteria (11 listed)
- Patients diagnosed with any malignant tumour within the past five years;
- Patients who have undergone transurethral resection or enucleation of the prostate;
- Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;
- Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);
- Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantum DetectionThis cohort will utilize archived plasma samples from a historical patient population with confirmed diagnoses (prostate cancer vs. controls). The objective is model development. The intervention involves analyzing these stored samples using the quantum sensing platform to extract multi-modal cfDNA features (e.g., fragmentomics, methylation). This data is then used to train and optimize the initial AI diagnostic algorithm, establishing the core model before prospective validation. | Diagnostic test | Retrospective Testing Cohort |
| Quantum DetectionThis cohort will prospectively enroll new patients with suspected prostate cancer from the same institution as testing cohort. The objective is initial model validation. The intervention entails collecting pre-biopsy blood samples from these participants. The cfDNA from these fresh samples is analyzed using the locked model from the training phase. The model's predictions are then compared against the gold-standard prostate biopsy results to assess initial diagnostic performance. | Diagnostic test | Prospective Internal Validation Cohort |
| Quantum DetectionThis cohort will prospectively recruit patients from multiple independent clinical centers. The objective is to test the model's generalizability. The intervention involves standardized blood collection across all external sites, with samples sent to a central lab for blinded cfDNA analysis using the finalized, locked-down model. | Diagnostic test | Prospective external Validation Cohort |
Primary outcome
Area under the receiver operating characteristic curve (AUC-ROC) for the predictive model in the general population for prostate cancer.
Time frame: Through primary completion which may take 12 months.
Sensitivity of the predictive model in detecting prostate cancer within the general population.
Time frame: Through primary completion which may take 12 months.
Specificity of the predictive model in detecting prostate cancer within the general population.
Time frame: Through primary completion which may take 12 months.
3 secondary outcomes
Area under the ROC curve for the predictive model in identifying prostate cancer within the PSA grey zone cohort.
Time frame: Through primary completion which may take 12 months.
Sensitivity of the predictive model in identifying prostate cancer within the PSA grey zone cohort.
Time frame: Through primary completion which may take 12 months.
The specificity of the predictive model in identifying prostate cancer among individuals in the PSA grey zone.
Time frame: Through primary completion which may take 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duocai Li contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostate Hypertrophy(BPH) and Prostate Cancer (Diagnosis), run by Shanghai Changzheng Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shancheng Ren, MD,PhD (86021-81886999, renshancheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic curve (AUC-ROC) for the predictive model in the general population for prostate cancer. (time frame: Through primary completion which may take 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.