Multicenter, Prospective Clinical Study of the Serum Raman Spectroscopy Intelligent System for the Diagnosis of Prostate Cancer

May 3, 2023 updated by: RenJi Hospital

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200120
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Principal Investigator:
          • Wei Xue, Doctor
        • Principal Investigator:
          • JiaHua Pan, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Patients with suspected prostate cancer and meet the Chinese Guidelines for Prostate Cancer (2014 edition)
  2. PSA≤20;
  3. The ECGO score was 0-1, and the cardiopulmonary function tolerated prostate biopsy;
  4. 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".

Exclusion criteria:

  1. Previous history of other cancer;
  2. Metabolic disorders caused by chronic renal failure or metabolic diseases, obviously abnormal blood sugar, blood lipid and plasma protein;
  3. Previously taking 5- α reductase inhibitor drug;
  4. History of acute prostatitis or minimally invasive surgery inside the prostate cavity for 3 months prior to puncture;
  5. History of multiple blood transfusion;
  6. Failure to cooperate with or refuse to participate in the clinical trial later.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Serum Raman spectroscopy intelligent diagnostic system
Intelligent diagnostic system based on Raman spectrum of serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2023.6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Changhai Hospital
Peking University People's Hospital
Shanghai Zhongshan Hospital
Tongji Hospital
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 10, 2023

Primary Completion (Anticipated)

June 10, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2023-026-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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