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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758455
Enrollment
75
Registered
2021-02-17
Start date
2021-02-14
Completion date
2021-04-30
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Relapse, Wilms Tumor

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.

Interventions

DIAGNOSTIC_TESTP53, Ki67 and Cyclin A IHC.

P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To test the ability of P53, Ki67 and cyclin A to predict Wilms' tumour recurrence and progression.2 monthsBy correlating P53, Ki67 and cyclin A IHC to tumor stage, histopathology and patients' follow-up.

Countries

Egypt

Contacts

Primary ContactAhmed Atwa, MSc
Ahmed_Atwa_88@yahoo.com01009440128
Backup ContactAhmed I Atwa, MSc
ahmedatwa@mans.edu.eg0502362383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026