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

Death Clinical Trial

Official title:

P53, Ki67 and Cyclin A Immunohistochemical Staining as Predictors for Wilms' Tumour Aggressiveness and Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758455
• Other study ID #: IHS for Wilms tumour relapse
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2021
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: Mansoura University
• Contact: Ahmed Atwa, MSc
• Phone: 01009440128
• Email: Ahmed_Atwa_88[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Recurrence
• Relapse
• Wilms Tumor

Intervention

Diagnostic Test:
• P53, Ki67 and Cyclin A IHC.
P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.

Locations

Country	Name	City	State
Egypt	Mansoura Urology and Nephrology Center. Faculty of Medicine, Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months