Clinical trial NCT04758455: The Use of Immunohistochemical Staining for the Prediction of Wilms Tumour Progression and Recurrence
Official title: P53, Ki67 and Cyclin A Immunohistochemical Staining as Predictors for Wilms' Tumour Aggressiveness and Recurrence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wilms Tumor
Relapse
Death
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 75
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To test the ability of P53, Ki67 and cyclin A to predict Wilms' tumour recurrence and progression.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Urology and Nephrology Center. Faculty of Medicine, Mansoura University
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed Abdelhameed, MSc
role: STUDY_CHAIR
affiliation: Mansoura University
name: Tamer Helmy, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Ashraf Hafez, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Adel Nabeeh, MD
role: PRINCIPAL_INVESTIGATOR
References: