Role of USP35 in the Detection of Ferroptosis in Juvenile Autoimmune Hepatitis

NCT06896383 | Not Yet Recruiting

• 1 other identifier: USP35 in autoimmune hepatitis
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To evaluate the immunohistochemical expression of USP35 in cases of juvenile autoimmune hepatitis and control cases.
2. 2.To correlate this with the level of necro-inflammation and extent of fibrosis using Massion's trichrome stain in cases of juvenile autoimmune hepatitis.

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (1)

• Expression of USP35 in cases of juvenile autoimmune hepatitis

  Expression of USP35 is an indicator of ferroptosis so the investigators can detect the relationship between ferroptosis and the pathogenesis of juvenile autoimmune hepatitis

  baseline

Secondary Outcomes (1)

• To correlate the expression of USP35 with the level of necro-inflammation and extent of fibrosis using Massion's trichrome stain in cases of juvenile autoimmune hepatitis

  baseline

Study Arms (2)

cases with juvenile autoimmune hepatitis

patients who are diagnosed physically, clinically, and histologically with juvenile autoimmune hepatitis

control group

children with near-normal liver biopsy

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cases with adequate tissue in the paraffin blocks from Laboratories of Surgical Pathology at Assiut University and private labs will be recruited in this study during 5 years period from 2019 to 2024. Approximately 50 cases of juvenile autoimmune hepatitis and 10 control cases will be taken Histological diagnosis of H\&E stained slides will be reviewed and the histological criteria will be assessed.

You may qualify if:

• Patients aged between one day and 18 years (children)
• patients diagnosed clinically and physically with juvenile autoimmune hepatitis including seronegative autoimmune hepatitis cases

You may not qualify if:

• Cases with inadequate tissue in the paraffin block
• Children with viral hepatitis
• patients above the age of 18 years old

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Howadya Ismail Hassan El Sayed, PhD

  Assiut University

  STUDY DIRECTOR

• Moemen Mostafa Ahmed Hafez, PhD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mariam Mohamed Rashwan, bachelor's degree

CONTACT

+20 1158056572; Mariam.rashwan@aun.edu.eg

Shimaa Hassan Shaban, PhD

CONTACT

+20 1090651710; shimaahassan@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 26, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03