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| Name | Class |
|---|---|
| Shanghai Shen Kang Hospital Development Center | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate cancer patients | Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draws | Other | Blood draws, from peripheral veins, each time 2 tubes, each 5 ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique | This step should be completed within the day when the peripheral venous blood is drawn. | 1 day before operation |
| Pathological findings (whether the patient has: 1.OC, organ confined; 2.EPE, extraprostatic extension; 3. SVI, seminal vesicle invasion; 4. LNI, lymph node invasion) during the radical prostectomy, confirmed by pathology section result | The pathology section evaluation will be done by two pathologists independently. A third pathology expert will join to make a final decision if opposite results are given by the two pathologists. | On the day of operation |
| CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique | This step should be completed within the day when the peripheral venous blood is drawn. | 3 months after operation |
| CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique | This step should be completed within the day when the peripheral venous blood is drawn. | 12 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate specific antigen (PSA) level measurement using peripheral venous blood | The blood should be drawn together with that for CTC detection | 3 months after operation |
| Prostate specific antigen (PSA) level measurement using peripheral venous blood |
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Inclusion Criteria:
Exclusion Criteria:
Severe concomitant disease or infection.
ALT or AST > 2.5 ULN, or total bilirubin > 1.5 ULN; Creatinine >177umol/L(2.5mg/dL)ï¼›Plt < 100,000/uL, Neutrophil <1,500/uL.
Known or suspected brain metastasis or leptomeningeal carcinomatosis.
Another malignancy in the last 5 years, excluding completely cured melanoma.
Severe cardiovascular disease, including:
Myocardial infarct within 6 months; Uncontrolled angina pectoris within 3 months; Congestive heart failure; Ventricular arrhythmia history with clinical significance; Morbiz type â…¡ or complete heart block
Major surgery (general anesthesia) within 4 weeks.
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Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Qi, MD. | Contact | 021-20578080 | jasonqi@sh163.net | |
| Jie Ding, MD.; Postdoc. | Contact | +8613564315425 | 769233885@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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Fresh blood 5 ml *2
The blood should be drawn together with that for CTC detection
| 6 months after operation |
| PSA level measurement using peripheral venous blood | The blood should be drawn together with that for CTC detection | 9 months after operation |
| Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan | Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection. | 12 months after operation |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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