Prostate CancerNCT05854940
Multicenter, Prospective Clinical Study of the Serum Raman Spectroscopy Intelligent System for the Diagnosis of Prostate Cancer
An observational study of Prostate Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
At present, the most commonly used clinical screening tool is based on prostate-specific antigen (PSA) examination. Because PSA is a tissue-specific rather than a tumor-specific marker, it has low specificity and sensitivity for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Serum Raman spectroscopy intelligent diagnostic system
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected prostate cancer and meet the Chinese Guidelines for Prostate Cancer (2014 edition); including: 1. Digital rectal examination found prostate nodules, any PSA. 2. B ultrasound, CT, MRI found abnormal signals, any PSA. 3. PSA> 10 ng/ml, any f / t PSA and PSAD values. 4. PSA 4 ~ 10 ng/ml, abnormal f / t PSA value or abnormal PSD value.
Who may be able to join
- Patients with suspected prostate cancer and meet the Chinese Guidelines for Prostate Cancer (2014 edition)
- PSA≤20;
- The ECGO score was 0-1, and the cardiopulmonary function tolerated prostate biopsy;
- After being fully informed of the purpose and possible risks of the study, the patient agrees to participate in the trial and signed the "Informed Consent for the use of clinical samples".
Who cannot join
- Previous history of other cancer;
- Metabolic disorders caused by chronic renal failure or metabolic diseases, obviously abnormal blood sugar, blood lipid and plasma protein;
- Previously taking 5- α reductase inhibitor drug;
- History of acute prostatitis or minimally invasive surgery inside the prostate cavity for 3 months prior to puncture;
- History of multiple blood transfusion;
- Failure to cooperate with or refuse to participate in the clinical trial later.
Trial locations and contacts
1 site in 1 country.
Xiaoguang Shao, Doctor contact
China1 site, 1 recruiting
- Recruiting
RenJi hospital, school of Medicine, Shanghai Jiao Tong University
Shanghai, 200120
Xiaoguang Shao, Doctor, shaoxgg@163.com
Wei Xue, Doctor
About this study
At present, the most commonly used clinical screening tool is based on prostate-specific antigen (PSA) examination. Because PSA is a tissue-specific rather than a tumor-specific marker, it has low specificity and sensitivity for prostate cancer. Although these PSA-related diagnostic models (PHI, 4Kscore) have been proved to improve the sensitivity and specificity of the early diagnosis of prostate cancer, they still do not meet the requirements of accurate diagnosis. Therefore, it is extremely important to develop a diagnosis tool with higher specificity, sensitivity and accuracy in the current prostate tumor screening strategy.
Raman spectroscopy (Raman Spectrum, RS) as a non-invasive and high specificity of material molecular detection technology, can be obtained in the molecular level, thus sensitive to detect biological samples tumor metabolism related proteins, nucleic acids, lipids and sugar composition of bio-molecules changes. As scientists pointed out in a literature in "chemical society reviews"in 2020, although SERS technology has shown good diagnostic efficacy in lots of preclinical studies in multiple tumors, it is limited to a generally small sample size and lacks external validation. There for, a clinical study of Raman spectra for tumor diagnosis is needed, which meets the following requirements: 1.An objective, fast and practical application of Raman spectral data processing is needed and deep learning method may be the best classification method; 2. It requires multicenter and large clinical samples to train deep learning diagnostic model, and verify its true efficacy through external data of prospective study.
In our preliminary study,we have collected Raman spectra data from a large cohort of 2899 patients and constructed Raman intelligent diagnostic system based on CNN model. The intelligent diagnostic system achieved accuracy of 83%. In order to obtain the highest level of clinical evidence and truly realize clinical transformation, this prospective, multi-center clinical study is designed to verify the intelligent diagnostic system for early diagnosis of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Serum Raman spectroscopy intelligent diagnostic system
- Keywords
- Prostate Cancer, Raman spectroscopy, Early diagnosis, artificial intelligence
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Raman spectroscopy intelligent diagnostic systemDiagnostic test
Intelligent diagnostic system based on Raman spectrum of serum
| Study group | Role | What they receive |
|---|---|---|
| Eligible participants for early diagnosis of prostate cancer | According to the 2014 edition of China Prostate Cancer Diagnosis and Treatment Guidelines, patients need to undergo prostate biopsy Receives: Diagnostic Test: Serum Raman spectroscopy intelligent diagnostic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of the Serum Raman Spectroscopy Intelligent System
According to the final pathology results of prostate biopsy, count the accuracy of Serum Raman Spectroscopy Intelligent System for prostate cancer diagnosis.
Measured: 2023.6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 Jun 2023 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Changhai Hospital, Ruijin Hospital, Tongji Hospital, Peking University People's Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854940
- Sponsor's protocol ID
- LY2023-026-B
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Clinical Study of the Serum Raman Spectroscopy Intelligent System for the Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05854940
- Acronym / sponsor ID
- LY2023-026-B
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Raman spectroscopy, Early diagnosis, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Changhai Hospital, Ruijin Hospital, Tongji Hospital, Peking University People's Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 11 May 2023 (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.
At present, the most commonly used clinical screening tool is based on prostate-specific antigen (PSA) examination. Because PSA is a tissue-specific rather than a tumor-specific marker, it has low specificity and sensitivity for prostate cancer. Although these PSA-related diagnostic models (PHI, 4Kscore) have been proved to improve the sensitivity and specificity of the early diagnosis of prostate cancer, they still do not meet the requirements of accurate diagnosis. Therefore, it is extremely important to develop a diagnosis tool with higher specificity, sensitivity and accuracy in the current prostate tumor screening strategy.
Raman spectroscopy (Raman Spectrum, RS) as a non-invasive and high specificity of material molecular detection technology, can be obtained in the molecular level, thus sensitive to detect biological samples tumor metabolism related proteins, nucleic acids, lipids and sugar composition of bio-molecules changes. As scientists pointed out in a literature in "chemical society reviews"in 2020, although SERS technology has shown good diagnostic efficacy in lots of preclinical studies in multiple tumors, it is limited to a generally small sample size and lacks external validation. There for, a clinical study of Raman spectra for tumor diagnosis is needed, which meets the following requirements: 1.An objective, fast and practical application of Raman spectral data processing is needed and deep learning method may be the best classification method; 2. It requires multicenter and large clinical samples to train deep learning diagnostic model, and verify its true efficacy through external data of prospective study.
In our preliminary study,we have collected Raman spectra data from a large cohort of 2899 patients and constructed Raman intelligent diagnostic system based on CNN model. The intelligent diagnostic system achieved accuracy of 83%. In order to obtain the highest level of clinical evidence and truly realize clinical transformation, this prospective, multi-center clinical study is designed to verify the intelligent diagnostic system for early diagnosis of prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible participants for early diagnosis of prostate cancer | – | Diagnostic Test: Serum Raman spectroscopy intelligent diagnostic systemAccording to the 2014 edition of China Prostate Cancer Diagnosis and Treatment Guidelines, patients need to undergo prostate biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected prostate cancer and meet the Chinese Guidelines for Prostate Cancer (2014 edition); including: 1. Digital rectal examination found prostate nodules, any PSA. 2. B ultrasound, CT, MRI found abnormal signals, any PSA. 3. PSA> 10 ng/ml, any f / t PSA and PSAD values. 4. PSA 4 ~ 10 ng/ml, abnormal f / t PSA value or abnormal PSD value.
Key inclusion criteria (4 listed)
- Patients with suspected prostate cancer and meet the Chinese Guidelines for Prostate Cancer (2014 edition)
- PSA≤20;
- The ECGO score was 0-1, and the cardiopulmonary function tolerated prostate biopsy;
- After being fully informed of the purpose and possible risks of the study, the patient agrees to participate in the trial and signed the "Informed Consent for the use of clinical samples".
Key exclusion criteria (6 listed)
- Previous history of other cancer;
- Metabolic disorders caused by chronic renal failure or metabolic diseases, obviously abnormal blood sugar, blood lipid and plasma protein;
- Previously taking 5- α reductase inhibitor drug;
- History of acute prostatitis or minimally invasive surgery inside the prostate cavity for 3 months prior to puncture;
- History of multiple blood transfusion;
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 |
|---|---|---|
| Serum Raman spectroscopy intelligent diagnostic systemIntelligent diagnostic system based on Raman spectrum of serum | Diagnostic test | Eligible participants for early diagnosis of prostate cancer |
Primary outcome
The accuracy of the Serum Raman Spectroscopy Intelligent System
Time frame: 2023.6
According to the final pathology results of prostate biopsy, count the accuracy of Serum Raman Spectroscopy Intelligent System for prostate cancer diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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. This study is not recruiting at the moment.
Xiaoguang Shao, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by RenJi Hospital at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Xue, Doctor (+8613120751506, xuewei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the Serum Raman Spectroscopy Intelligent System (time frame: 2023.6). 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 11 May 2023.