Mie Mohammed

MREC Reviewer Comment

Protocol Title

Insights into predicting hepatocellular carcinoma in cirrhotic DAA-response/failure HCV-Egyptian patients using circulating HCV core antigen, CD163, IL-10/12 levels and Claudin-1/TGF-β1 expression profiles, and their prognostic capacity of immunotherapy outcome in HCV-related HCC patients.

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

if the study is retrospective and the data not feasible you can ask for waiver for informed consent

Please correct the methodology of protocol to a retrospective ( archived sample)

Comment to the Committee

لا يوجد نموذج 90 بموافقة القسم

How you are going to protect the confidentiality of data?

This study doesn't require any private data (Name, Age, etc); only serum samples that will be obtained through the clinician in our teamwork; Dr. Yasser Elesnawy ?????? needs explanation
4- تعديل نوع الدراسة من تداخلية إلى ملاحظية حيث انة لم يتم التداخل باى شىء

5--مذكور فى الموافقة المستنيرة بان نوع الدراسى Retrospective ????.

6- مذكور فى الموافقة المستنيرة بانة سوف يتم عمل تحاليل و فحوصات قبل العلاج و كل شهرين بعد

???? needs explanation بداية العلاج methodology