Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)
NCT ID: NCT05947188
Last Updated: 2024-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
808 participants
INTERVENTIONAL
2023-11-01
2024-12-31
Brief Summary
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Detailed Description
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We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（\>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.
This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Sample for Circulating Tumoral Cells
Sampling of Circulating Tumoral Cells will be done
prostate cancer diagnosis
prostate cancer diagnosis
Interventions
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prostate cancer diagnosis
prostate cancer diagnosis
Eligibility Criteria
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Inclusion Criteria
2. men ≥ 50 years；
3. tPSA level of 4-10 ng/ml, and fPSA/tPSA\<0.16;
4. tPSA level of \>10 ng/ml；
5. With abnomal mpMRI、PET/CT、TRUS or DRE;
6. fully understand the clinical trial protocol and sign the informed consent;
2. previous diagnosis of prostate carcinoma ;
3. symptomatic of acute prostatitis;
4. local anesthetic allergy patients;
5. cannot tolerate prostate biopsy or has contraindication to biopsy;
6. patients judged by the investigator to be unsuitable to participate in the clinical trial;
50 Years
80 Years
MALE
No
Sponsors
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Tianjin Medical University Second Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Affiliated Hospital of Nantong University
OTHER
Wujin People's Hospital
OTHER
Seventh Medical Center of PLA Army General Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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yang gao
Role: STUDY_CHAIR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Countries
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Central Contacts
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liang liang
Role: CONTACT
Facility Contacts
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Other Identifiers
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XJTU1AF2022LSL-010
Identifier Type: -
Identifier Source: org_study_id
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