Wilms TumorNCT04758455
The Use of Immunohistochemical Staining for the Prediction of Wilms Tumour Progression and Recurrence
A study testing P53, Ki67 and Cyclin A IHC. in people with Wilms Tumor and Relapse, run by Mansoura University at 1 site in Egypt.
Trial summary
Wilms' tumour staging and grading are used to give an idea about the prognosis. Advanced staging, diffuse anaplasia, predominant blastemal elements and lymph node invasion are indicators of poor prognosis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Wilms Tumor, Relapse, Death
- What is being tested?
- P53, Ki67 and Cyclin A IHC.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2021to Apr 2021
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children presented with Wilms' tumour at the Urology and Nephrology Center, Mansoura University, Mansoura, Egypt from 2000 to 2014.
Who cannot join
- Preoperative chemotherapy (due to areas of necrosis and haemorrhage hindering immunohistochemical staining).
- Patients with incomplete follow-up data.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Urology and Nephrology Center. Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Ahmed I Atwa, MSc, 01009440128, ahmedatwa@mans.edu.eg
About this study
Official title: P53, Ki67 and Cyclin A Immunohistochemical Staining as Predictors for Wilms' Tumour Aggressiveness and Recurrence
Wilms' tumour staging and grading are used to give an idea about the prognosis. Advanced staging, diffuse anaplasia, predominant blastemal elements and lymph node invasion are indicators of poor prognosis. In spite of using the previously mentioned parameters, some tumours which were considered of low risk did not respond to therapy and eventually resulted in mortality. In contrast, other tumours assumed to be of poor prognosis responded dramatically to treatment.
In light of the above, it is crucial to search for predictors of Wilms' tumour prognosis other than tumour staging and grading. Many immunohistochemical (IHC) stains have been studied as prognostic markers for nephroblastoma in literature.
Read the detailed description
P53 is a tumour suppressor gene, and its mutation is identified in various types of human cancer. P53 protein accumulation in certain tumours is associated with tumour aggressiveness. The role of P53 expression in Wilms' tumour is not clear; however, most studies confirmed its correlation with advanced stages and anaplasia.
Ki67 is a nuclear antigen related to cell proliferation, and high Ki67 proliferation index (PI) is accompanied by tumour aggressiveness, distant metastasis and death. Advanced stages and clinical progression of WT were found to be associated with high Ki67 PI. On the other hand, some authors concluded that it may not be a dependable prognostic marker.
The cyclin-dependent kinases (CDKs) have a role in transitions between cell cycle phases with the need of cyclins association for their activity. IHC assessment of cell cycle proteins has a diagnostic use in histopathology. Correlation between poor prognosis and overexpression of cyclin A was confirmed in different entities of human cancer such as medulloblastoma and ovarian carcinoma. A recent study deduced that cyclin A overexpression may be associated with the poor prognosis of WT.
- Conditions
- Wilms Tumor, Relapse, Death
- Being tested
- P53, Ki67 and Cyclin A IHC.
- Medical subject headings
- Wilms Tumor, Recurrence, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P53, Ki67 and Cyclin A IHC.Diagnostic test
P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.
| Study group | Role | What they receive |
|---|---|---|
| P53 IHC | Experimental | P53 staining density and intensity will be calculated. To assess P53 density in a semiquantitative way, a score of 0 will be given assigned if less than 5% of tumour cells expressed p53, 1 if 5% to 50% expressed p53 and 2 if more than 50% stained positive for p53. To evaluate P53 intensity, a score of 0 means weak or absent staining, 1 refers to the intermediate intensity and 2 stands for strong intensity. Receives: Diagnostic Test: P53, Ki67 and Cyclin A IHC. |
| Ki67 IHC | Experimental | Ki67 proliferation index will be used to detect rapidly proliferating cells which means the percentage of positive Ki67 cells over 5 high power fields. It will be semiquantitatively graded as low, moderate, or high and correlated with histological staging. Receives: Diagnostic Test: P53, Ki67 and Cyclin A IHC. |
| Cyclin A IHC | Experimental | Regarding Cyclin A, a standard peroxidase-conjugated streptavidin-biotin labelling was used for visualization, with 3,3 diaminobenzidine as chromogen. Level of cyclin A expression will be classified as absent (-), focal (+), moderate (++) diffuse (+++). Receives: Diagnostic Test: P53, Ki67 and Cyclin A IHC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the ability of P53, Ki67 and cyclin A to predict Wilms' tumour recurrence and progression.
By correlating P53, Ki67 and cyclin A IHC to tumor stage, histopathology and patients' follow-up.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start14 Feb 2021
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilms TumorStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Ibrahim Atwa, Mansoura University
- Investigators
- Mohamed Abdelhameed, MSc, Study chair, Mansoura UniversityTamer Helmy, MD, Study chair, Mansoura UniversityAshraf Hafez, MD, Study director, Mansoura UniversityAdel Nabeeh, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758455
- Sponsor's protocol ID
- IHS for Wilms tumour relapse
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P53, Ki67 and Cyclin A Immunohistochemical Staining as Predictors for Wilms' Tumour Aggressiveness and Recurrence
- ClinicalTrials.gov ID
- NCT04758455
- Acronym / sponsor ID
- IHS for Wilms tumour relapse
- Conditions
- Wilms Tumor, Relapse, Death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 17 Feb 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.
Wilms' tumour staging and grading are used to give an idea about the prognosis. Advanced staging, diffuse anaplasia, predominant blastemal elements and lymph node invasion are indicators of poor prognosis. In spite of using the previously mentioned parameters, some tumours which were considered of low risk did not respond to therapy and eventually resulted in mortality. In contrast, other tumours assumed to be of poor prognosis responded dramatically to treatment.
In light of the above, it is crucial to search for predictors of Wilms' tumour prognosis other than tumour staging and grading. Many immunohistochemical (IHC) stains have been studied as prognostic markers for nephroblastoma in literature.
Detailed description
P53 is a tumour suppressor gene, and its mutation is identified in various types of human cancer. P53 protein accumulation in certain tumours is associated with tumour aggressiveness. The role of P53 expression in Wilms' tumour is not clear; however, most studies confirmed its correlation with advanced stages and anaplasia.
Ki67 is a nuclear antigen related to cell proliferation, and high Ki67 proliferation index (PI) is accompanied by tumour aggressiveness, distant metastasis and death. Advanced stages and clinical progression of WT were found to be associated with high Ki67 PI. On the other hand, some authors concluded that it may not be a dependable prognostic marker.
The cyclin-dependent kinases (CDKs) have a role in transitions between cell cycle phases with the need of cyclins association for their activity. IHC assessment of cell cycle proteins has a diagnostic use in histopathology. Correlation between poor prognosis and overexpression of cyclin A was confirmed in different entities of human cancer such as medulloblastoma and ovarian carcinoma. A recent study deduced that cyclin A overexpression may be associated with the poor prognosis of WT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P53 IHC | Experimental | Diagnostic Test: P53, Ki67 and Cyclin A IHC.P53 staining density and intensity will be calculated. To assess P53 density in a semiquantitative way, a score of 0 will be given assigned if less than 5% of tumour cells expressed p53, 1 if 5% to 50% expressed p53 and 2 if more than 50% stained positive for p53. To evaluate P53 intensity, a score of 0 means weak or absent staining, 1 refers to the intermediate intensity and 2 stands for strong intensity. |
| Ki67 IHC | Experimental | Diagnostic Test: P53, Ki67 and Cyclin A IHC.Ki67 proliferation index will be used to detect rapidly proliferating cells which means the percentage of positive Ki67 cells over 5 high power fields. It will be semiquantitatively graded as low, moderate, or high and correlated with histological staging. |
| Cyclin A IHC | Experimental | Diagnostic Test: P53, Ki67 and Cyclin A IHC.Regarding Cyclin A, a standard peroxidase-conjugated streptavidin-biotin labelling was used for visualization, with 3,3 diaminobenzidine as chromogen. Level of cyclin A expression will be classified as absent (-), focal (+), moderate (++) diffuse (+++). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children presented with Wilms' tumour at the Urology and Nephrology Center, Mansoura University, Mansoura, Egypt from 2000 to 2014.
Key exclusion criteria (2 listed)
- Preoperative chemotherapy (due to areas of necrosis and haemorrhage hindering immunohistochemical staining).
- Patients with incomplete follow-up data.
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 |
|---|---|---|
| P53, Ki67 and Cyclin A IHC.P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour. | Diagnostic test | Cyclin A IHC, Ki67 IHC, P53 IHC |
Primary outcome
To test the ability of P53, Ki67 and cyclin A to predict Wilms' tumour recurrence and progression.
Time frame: 2 months
By correlating P53, Ki67 and cyclin A IHC to tumor stage, histopathology and patients' follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Mohamed Abdelhameed, MSc study chair
Mansoura University
Tamer Helmy, MD study chair
Mansoura University
Ashraf Hafez, MD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P53, Ki67 and Cyclin A IHC. in people with Wilms Tumor and Relapse, run by Mansoura 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 1 inclusion and 2 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 17 Feb 2021. 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 Ahmed Atwa, MSc (01009440128, Ahmed_Atwa_88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the ability of P53, Ki67 and cyclin A to predict Wilms' tumour recurrence and progression. (time frame: 2 months). 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 17 Feb 2021.