P53, Ki67 and Cyclin A Immunohistochemical Staining as Predictors for Wilms' Tumour Aggressiveness and Recurrence
Sponsor study identifier
interventional
75
1 country
1
Study Start
February 14, 2021
Actual (reported)Primary Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2021
Actual (reported)February 14, 2021
Actual (reported)February 17, 2021
Actual (reported)March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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.
P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.
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Mansoura Urology and Nephrology Center. Faculty of Medicine, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Mohamed Abdelhameed, MSc
Mansoura University
Tamer Helmy, MD
Mansoura University
Ashraf Hafez, MD
Mansoura University
Adel Nabeeh, MD
Mansoura University
First Submitted
February 14, 2021
First Posted
February 17, 2021
Study Start
February 14, 2021
Actual (reported)Primary Completion
March 2021
Estimated (date passed)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 (+++).
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 17, 2021
Record last verified: 2021-02
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