National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Fabrication of Carboxymethyl Cellulose/PVA-Sulfonamide Composite for the Amelioration of Benign Prostatic Hyperplasia in Rats via Modulating NRF2/NF-κB, PI3K/AKT, and NOX-2/NLRP3 Pathways

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

The protocol needs modifications:

Comment to the Committee

The protocol needs modifications:

العنوان العربى: يجب تغير كلمة الفئران بالجرذان .. ايضا يفضل تعريب الاختصارات المكتوبة بالانجليزية

2- It is known that azo dyes are toxic and cause DNA damage. How are they used in cancer treatment? This was not explained in the background.

3. It written the protocol has not been reviewed despite the existence of Form 90.

4. The methods are written in the past tense

5. The protocol states that prostate cancer cells (PC3 cells) were obtained from the American Cancer Society (ATCC). How? Was it through collaboration or purchase?

6. The protocol does not explain how rats with benign prostatic hyperplasia (BPH) were obtained. How was the tumor induced?

7- Some abbreviations are unclear, such as SD... (The BPH+SD group will be injected with testosterone, then SD will be given orally???.. Also, the BPH+SO group will be injected with testosterone, then SO will be given orally.)

8- Calculate the sample size: The calculation for the sample size was not explained.

9- The protocol states a study duration of 2 months, while the Gantt chart indicates 7 months.

10- When PI asked whether human biological samples would be imported into Egypt, the answer was no, despite the fact that they stated they would import prostate cancer cells from the American group!!!!.

Informed consent form:

N/A

Human update comments for researcher

Wagdy Khalil

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Animal update comments for researcher

Wagdy Khalil

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