Prostatic CarcinomaNCT05428319
Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers
An observational study of Prostatic Carcinoma, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Carcinoma
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
Study population: Formalin-fixed and paraffin embedded prostatic tissue blocks from 70 patients
Who may be able to join
- Trans-rectal ultrasound guided biopsy (TRUS) procedure, transurethral resection prostatectomy (TURP) and radical prostatectomy.
- Prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma
Who cannot join
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers: An Immunohistochemical Study
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.
Read more
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.
- Conditions
- Prostatic Carcinoma
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Prostatic Carcinoma
Immunohistochemical Expression of STEAP-1 and p40 in Prostatic carcinoma and mimickers
Measured: One or two days after staining sections with the markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study startDec 2022 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Bakr Ahmed, Sohag University
- Investigators
- Aliaa Bakr, Principal investigator, Faculty of medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428319
- Sponsor's protocol ID
- Soh-Med-22-06-14
- Status last verified
- Sep 2022
- First submitted
- 16 Jun 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of STEAP-1 and p40 in Prostatic Carcinoma and Its Mimickers: An Immunohistochemical Study
- ClinicalTrials.gov ID
- NCT05428319
- Acronym / sponsor ID
- Soh-Med-22-06-14
- Conditions
- Prostatic Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Formalin-fixed and paraffin embedded prostatic tissue blocks from 70 patients
Key inclusion criteria (2 listed)
- Trans-rectal ultrasound guided biopsy (TRUS) procedure, transurethral resection prostatectomy (TURP) and radical prostatectomy.
- Prostatic adenocarcinoma and prostatic lesions that mimic prostatic adenocarcinoma
Key exclusion criteria (3 listed)
- Patients with recurrence of the primary tumor.
- Patients with a history of preoperative chemotherapy and/or radiotherapy.
- Insufficient or tiny tissue biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of Prostatic Carcinoma
Time frame: One or two days after staining sections with the markers
Immunohistochemical Expression of STEAP-1 and p40 in Prostatic carcinoma and mimickers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Bakr principal investigator
Faculty of medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Carcinoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliaa B Ahmed (01062157907, aliaa.bek0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Prostatic Carcinoma (time frame: One or two days after staining sections with the markers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.