The Use of Immunohistochemical Staining for the Prediction of Wilms Tumour Progression and Recurrence

February 16, 2021 updated by: Ahmed Mohammed Ibrahim Atwa, Mansoura University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Recruiting
        • Mansoura Urology and Nephrology Center. Faculty of Medicine, Mansoura University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All children presented with Wilms' tumour at the Urology and Nephrology Center, Mansoura University, Mansoura, Egypt from 2000 to 2014.

Exclusion Criteria:

  • Preoperative chemotherapy (due to areas of necrosis and haemorrhage hindering immunohistochemical staining).
  • Patients with incomplete follow-up data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P53 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.
Diagnostic test: P53, Ki67 and Cyclin A IHC.
P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.
Experimental: Ki67 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.
Diagnostic test: P53, Ki67 and Cyclin A IHC.
P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.
Experimental: 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 (+++).
Diagnostic test: P53, Ki67 and Cyclin A IHC.
P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Mohamed Abdelhameed, MSc, Mansoura University
  • Study Chair: Tamer Helmy, MD, Mansoura University
  • Study Director: Ashraf Hafez, MD, Mansoura University
  • Principal Investigator: Adel Nabeeh, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2021

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

February 14, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHS for Wilms tumour relapse

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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