Multicenter, Prospective Clinical Study of the Serum Raman Spectroscopy Intelligent System for the Diagnosis of Prostate Cancer
1 other identifier
observational
490
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedStudy Start
First participant enrolled
June 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMay 11, 2023
May 1, 2023
Same day
April 26, 2023
May 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2023.6
Study Arms (1)
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
Interventions
Intelligent diagnostic system based on Raman spectrum of serum
Eligibility Criteria
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.
You may qualify if:
- 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".
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- Shanghai Zhongshan Hospitalcollaborator
- Changhai Hospitalcollaborator
- Ruijin Hospitalcollaborator
- Tongji Hospitalcollaborator
- Peking University People's Hospitalcollaborator
- First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
Study Sites (1)
RenJi hospital, school of Medicine, Shanghai Jiao Tong University
Shanghai, 200120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2023
First Posted
May 11, 2023
Study Start
June 10, 2023
Primary Completion
June 10, 2023
Study Completion
June 30, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05