Prostate AdenocarcinomaNCT04825691
ERG Protein Expression in Prostatic Adenocarcinoma and Its Clinicopathological Features
An observational study of Prostate Adenocarcinoma, run by Assiut University.
Trial summary
Evaluation the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Immunohistochemistry of prostate biopsy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2021to 23 May 2023
- 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 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All cases diagnosed as prostatic acinar adenocarcinoma.
Who may be able to join
- All cases diagnosed as prostatic acinar adenocarcinoma
Who cannot join
- Other types of prostatic cancer.
About this study
Official title: ERG Protein Expression in Prostatic Acinar Adenocarcinoma and Its Correlation With Clinicopathological Features
Evaluation the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.
Read the detailed description
Prostatic cancer is one of the most common malignancies in males and is the second leading cause of cancer-related deaths in males worldwide. The burden is expected to grow 1.7 million new cases and 499,000 new deaths by 2030. Although the diagnosis of prostatic carcinoma can usually be made on histological features, nowadays many immunohistochemical (IHC) markers are used to distinguish it from benign mimickers as well as in predicting prognosis and treatment. Out of these markers, Ets-related gene (ERG product) is a proto-oncogene which participates in chromosomal translocations and is frequently over expressed in prostatic carcinoma which harbors ERG-transmembrane protease, serine 2 fusion. ERG is a transcription factor belonging to the erythroblast transformation-specific (ETS) family. It is involved in many important cellular processes including differentiation, cell proliferation, angiogenesis, cell migration, hematopoiesis, and apoptosis. This proto-oncogene is expressed in the urogenital tract and hematopoietic cells. Gene fusions involving sequences of transmembrane protease serine 2 (promoter of TMPRSS2) and protein coding sequences of ERG result in over expression of ERG in prostatic tumors. This TMPRSS2-ERG fusion has been shown to occur in 50-70% cases of prostatic acinar adenocarcinoma in different studies. Genetic rearrangements were not identified in epithelial carcinomas until Tomlins et al. demonstrated ERG gene fusions in prostatic carcinoma.The presence of this fusion is now believed to be a critical event in the development of prostatic carcinoma.
TMPRSS2-ERG fusion results in constitutive expression of ERG oncoprotein resulting in enhanced proliferation and invasive potential of prostatic cancer cells. Moreover, TMPRSS2-ERG fusion gene product can be an important therapeutic target in prostatic cancer. Immunohistochemical (IHC) expression of ERG oncoprotein may serve as a surrogate biomarker of TMPRSS2-ERG fusion gene. Therefore in the present study we aimed to evaluate the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Immunohistochemistry of prostate biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry of prostate biopsyDiagnostic test
Sections of formalin fixed paraffin embedded tissue blocks will be stained with ERG oncoprotein. Antibody dilution, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| cases diagnosed as prostatic acinar adenocarcinoma | Not described Receives: Diagnostic Test: Immunohistochemistry of prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the ERG expression in prostatic acinar adenocarcinoma
Measured: 3 days
Secondary outcomes (1)
Correlation between ERG expression with clinicopathological features.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start4 May 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion23 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohammed Amin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825691
- Sponsor's protocol ID
- ERG protein in cancer prostate
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855Clark JP, Cooper CS. ETS gene fusions in prostate cancer. Nat Rev Urol. 2009 Aug;6(8):429-39. doi: 10.1038/nrurol.2009.127.
PubMed 19657377Kumar-Sinha C, Tomlins SA, Chinnaiyan AM. Recurrent gene fusions in prostate cancer. Nat Rev Cancer. 2008 Jul;8(7):497-511. doi: 10.1038/nrc2402. Epub 2008 Jun 19.
PubMed 18563191Berg KD, Vainer B, Thomsen FB, Roder MA, Gerds TA, Toft BG, Brasso K, Iversen P. ERG protein expression in diagnostic specimens is associated with increased risk of progression during active surveillance for prostate cancer. Eur Urol. 2014 Nov;66(5):851-60. doi: 10.1016/j.eururo.2014.02.058. Epub 2014 Mar 7.
PubMed 24630684
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERG Protein Expression in Prostatic Acinar Adenocarcinoma and Its Correlation With Clinicopathological Features
- ClinicalTrials.gov ID
- NCT04825691
- Acronym / sponsor ID
- ERG protein in cancer prostate
- Conditions
- Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 May 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 23 May 2023 (estimated)
- First posted
- 1 Apr 2021 (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.
Evaluation the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.
Detailed description
Prostatic cancer is one of the most common malignancies in males and is the second leading cause of cancer-related deaths in males worldwide. The burden is expected to grow 1.7 million new cases and 499,000 new deaths by 2030. Although the diagnosis of prostatic carcinoma can usually be made on histological features, nowadays many immunohistochemical (IHC) markers are used to distinguish it from benign mimickers as well as in predicting prognosis and treatment. Out of these markers, Ets-related gene (ERG product) is a proto-oncogene which participates in chromosomal translocations and is frequently over expressed in prostatic carcinoma which harbors ERG-transmembrane protease, serine 2 fusion. ERG is a transcription factor belonging to the erythroblast transformation-specific (ETS) family. It is involved in many important cellular processes including differentiation, cell proliferation, angiogenesis, cell migration, hematopoiesis, and apoptosis. This proto-oncogene is expressed in the urogenital tract and hematopoietic cells. Gene fusions involving sequences of transmembrane protease serine 2 (promoter of TMPRSS2) and protein coding sequences of ERG result in over expression of ERG in prostatic tumors. This TMPRSS2-ERG fusion has been shown to occur in 50-70% cases of prostatic acinar adenocarcinoma in different studies. Genetic rearrangements were not identified in epithelial carcinomas until Tomlins et al. demonstrated ERG gene fusions in prostatic carcinoma.The presence of this fusion is now believed to be a critical event in the development of prostatic carcinoma.
TMPRSS2-ERG fusion results in constitutive expression of ERG oncoprotein resulting in enhanced proliferation and invasive potential of prostatic cancer cells. Moreover, TMPRSS2-ERG fusion gene product can be an important therapeutic target in prostatic cancer. Immunohistochemical (IHC) expression of ERG oncoprotein may serve as a surrogate biomarker of TMPRSS2-ERG fusion gene. Therefore in the present study we aimed to evaluate the ERG expression in prostatic acinar adenocarcinoma and its association with clinicopathological features.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases diagnosed as prostatic acinar adenocarcinoma | – | Diagnostic Test: Immunohistochemistry of prostate biopsy |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases diagnosed as prostatic acinar adenocarcinoma.
Key inclusion criteria (1 listed)
- All cases diagnosed as prostatic acinar adenocarcinoma
Key exclusion criteria (1 listed)
- Other types of prostatic cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry of prostate biopsySections of formalin fixed paraffin embedded tissue blocks will be stained with ERG oncoprotein. Antibody dilution, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions | Diagnostic test | cases diagnosed as prostatic acinar adenocarcinoma |
Primary outcome
Evaluation the ERG expression in prostatic acinar adenocarcinoma
Time frame: 3 days
1 secondary outcome
Correlation between ERG expression with clinicopathological features.
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
- Background: PubMed 19657377Clark JP, Cooper CS. ETS gene fusions in prostate cancer. Nat Rev Urol. 2009 Aug;6(8):429-39. doi: 10.1038/nrurol.2009.127.
- Background: PubMed 18563191Kumar-Sinha C, Tomlins SA, Chinnaiyan AM. Recurrent gene fusions in prostate cancer. Nat Rev Cancer. 2008 Jul;8(7):497-511. doi: 10.1038/nrc2402. Epub 2008 Jun 19.
- Background: PubMed 24630684Berg KD, Vainer B, Thomsen FB, Roder MA, Gerds TA, Toft BG, Brasso K, Iversen P. ERG protein expression in diagnostic specimens is associated with increased risk of progression during active surveillance for prostate cancer. Eur Urol. 2014 Nov;66(5):851-60. doi: 10.1016/j.eururo.2014.02.058. Epub 2014 Mar 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma, run by Assiut University.
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 1 inclusion and 1 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the ERG expression in prostatic acinar adenocarcinoma (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825691, which also lists 4 linked publications.
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 1 Apr 2021.