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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05428319
Other study ID # Soh-Med-22-06-14
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2022
Est. completion date December 2024

Study information

Verified date September 2022
Source Sohag University
Contact Aliaa B Ahmed
Phone 01062157907
Email aliaa.bek0@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prostatic carcinoma is the second most common cancer in men with high incidence of morbidity and mortality. It is a common health problem. Most cases occur at the age of 50 years, reaching its peak at 60-70 years of age. Diagnosis of prostatic carcinoma is still a problematic issue as accurate diagnosis can be very challenging due to the presence of either a small focus of cancer or the presence of many benign mimickers of malignancy. Six transmembrane epithelial antigen of the prostate 1 (STEAP-1) is primarily localized at the cell membrane, mostly at cell-cell junctions, but it may also be found dispersed in the cytoplasm. In prostate, the expression of STEAP-1 is higher in neoplastic tissues compared to its restricted expression in normal prostatic samples. The antibody designated as p40 recognizes exclusively ΔNp63 and not TAp63. In prostate tissues, it has been shown that p40, the ΔNp63 isoform of p63, stains prostatic basal cells as reliable as p63 in most cases. Furthermore, aberrant staining of tumor cells was seen more rarely with p40 than with p63. In this study, the investigators hope to solve some problematic issues in diagnosis of prostatic carcinoma and reach the better way to distinguish prostatic carcinoma from mimicking lesions by using both STEAP-1 and p 40. Also, the way to detect cancer at early stage of development and its progression which is extremely important as it allows establishing the most effective treatment and predicting patient's outcome.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 2024
Est. primary completion date August 2024
Accepts healthy volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: - Trans-rectal ultrasound guided biopsy (TRUS) procedure, transurethral resection prostatectomy (TURP) and radical prostatectomy. - Prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma Exclusion Criteria: - Patients with recurrence of the primary tumor. - Patients with a history of preoperative chemotherapy and/or radiotherapy. - Insufficient or tiny tissue biopsies

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Aliaa Bakr Ahmed Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of Prostatic Carcinoma Immunohistochemical Expression of STEAP-1 and p40 in Prostatic carcinoma and mimickers One or two days after staining sections with the markers
See also
  Status Clinical Trial Phase
Terminated NCT02177526 - Imaging of High Grade Prostate Cancer N/A