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

NCT04758455 | Unknown

• 1 other identifier: IHS for Wilms tumour relapse
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Wilms Tumor; Relapse; Death

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

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 (+++).

Diagnostic Test: P53, Ki67 and Cyclin A IHC.

Interventions

P53, Ki67 and Cyclin A IHC. DIAGNOSTIC_TEST

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

Cyclin A IHC; Ki67 IHC; P53 IHC

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center. Faculty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Wilms Tumor; Recurrence; Death

Interventions

Genes, p53

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genes, Tumor Suppressor; Genes, Neoplasm; Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Genes, Recessive

Study Officials

• Mohamed Abdelhameed, MSc

  Mansoura University

  STUDY CHAIR

• Tamer Helmy, MD

  Mansoura University

  STUDY CHAIR

• Ashraf Hafez, MD

  Mansoura University

  STUDY DIRECTOR

• Adel Nabeeh, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Atwa, MSc

CONTACT

01009440128; Ahmed_Atwa_88@yahoo.com

Ahmed I Atwa, MSc

CONTACT

0502362383; ahmedatwa@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 17, 2021
• Study Start: February 14, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)