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Not yet recruitingNCT06896383Updated Mar 26, 2025

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

An observational study in Autoimmune Hepatitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Day to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
1 Day to 18 Years
Sex
All
01

Study summary

  1. To evaluate the immunohistochemical expression of USP35 in cases of juvenile autoimmune hepatitis and control cases.
  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.
Read the detailed description

Autoimmune hepatitis (AIH) is a rare and chronic inflammatory disease of the liver of unknown etiology characterized by loss of immune tolerance against liver antigens leading to progressive destruction of hepatic parenchyma and if untreated leads to end-stage liver disease.

It affects all ages with a peak incidence in pediatric age, where it is referred to as Juvenile Autoimmune Hepatitis (JAIH).JAIH is a long-term condition that varies in intensity over time. It occurs more frequently in females and is marked by increased levels of serum gamma globulins, the presence of autoantibodies in the bloodstream, and interface hepatitis observed in liver histology. JAIH can occur at any age from infancy to adolescence with an incidence reported of 0.4 and a prevalence of 3.0 per 100,000 children, respectively. Diagnosing the condition can be difficult and relies on a mix of clinical, biochemical, immunological, and histological indicators, as well as ruling out any other known causes that could present similar characteristics to JAIH. Certain circulating autoantibodies are crucial indicators of the disease. AIH type 1 is characterized by anti-smooth Muscle Antibodies (SMA) and/or anti-nuclear Antibodies (ANA), AIH type 2 is defined by the detection of anti-Liver-Kidney Microsomal antibody type 1 (LKM1) and/or of anti-Liver-Cytosol antibody type 1 (LC1). Approximately 20% of children exhibiting clinical, biochemical, and histological characteristics of autoimmune hepatitis do not have either typical or atypical autoantibodies, including anti-soluble liver antigen (anti-SLA) or atypical perinuclear anti-neutrophil cytoplasmic antibody (pANCA). These individuals form a diverse category of inflammatory liver conditions referred to as "seronegative autoimmune hepatitis." A liver biopsy is frequently required to make a diagnosis in atypical situations. Histological examination helps assess the level of necro-inflammation and the extent of fibrosis. The majority of biopsies taken from children with JAIH display moderate to severe interface hepatitis and lobular inflammation. Interface hepatitis is characterized by a pronounced infiltration of mononuclear cells in the portal and periportal areas, including CD4 and CD8 T cells, macrophages, plasma cells, and, on occasion, eosinophils. Emperipolesis, which involves the infiltration of CD8 T-lymphocytes into hepatocytes, is regarded as a distinctive characteristic of autoimmune hepatitis. Its occurrence is linked to more severe necroinflammatory traits and increased levels of fibrosis.

An overview of ferroptosis:

In 2012, Dixon et al. formally named a new type of cell death as ferroptosis, according to its characteristics when studying the mechanism by which erastin killed cancer cells with RAS mutations. Ferroptosis is a new mode of cell death. Morphologically, ferroptosis presents mainly in cells as reduced mitochondrial volume, increased bilayer membrane density and reduction or disappearance of mitochondrial cristae but the cell membrane is still intact, the nucleus is normal in size, and there is no condensation of chromatin; biochemically, there is intracellular glutathione (GSH) depletion and decreased activity of glutathione peroxidase 4 (GPX4), lipid peroxides cannot be metabolized by the GPX4-catalyzed reduction reaction, and Fe2+ oxidizes lipids in a Fenton-like manner, resulting in a large amount of ROS, which induces ferroptosis and genetically, ferroptosis is a biological process regulated by multiple genes. Ferroptosis mainly includes genetic changes in iron homeostasis and lipid peroxidation metabolism, but the specific regulatory mechanism is still in a need to be further studied.As research continues, ferroptosis has been shown to be involved in the development and progression of autoimmune and inflammatory diseases.

Mechanism of ferroptosis:

Iron metabolism and ferroptosis Iron plays a necessary role in mammalian physiological processes. However, excess iron is also fatal as it catalyzes the formation of reactive oxygen species (ROS). Thus, cellular and systemic iron metabolism is intricately and tightly controlled to prevent oxidative damage caused by imbalanced iron homeostasis. Intracellular iron metabolism is a complex physiological process, and cellular homeostasis depends on normal iron metabolism. In general, the balance of intracellular iron metabolism relies on the uptake, export, and utilization of iron ions.

Iron metabolism regulates cellular sensitivity to ferroptosis by regulating the labile iron pool (LIP) . Fe3+ in the circulation maintains homeostasis of iron metabolism through tight binding and release with transferrin (TF). Fe3+ is transported by TF and enters into cells after being recognized by transferrin receptor 1 (TFR1) at cell membranes. Next, Fe3+ is reduced to Fe2+ by reductase six-transmembrane epithelial antigen of prostate 3 (STEAP3). Subsequently, divalent metal transporter 1 (DMT1) released Fe2+ into the LIP. Intracellular LIP is mainly in the form of Fe2+. Suprisingly, it was lately found that in the absence of TF, solute carrier family 39 member 14 (SLC39A14) directly mediates the passage of extracellular non transferrin bound iron across the cell membrane into the intracellular compartment and causes ferroptosis.

Due to the instability and high reactivity of Fe2+, excess Fe2+ generates hydroxyl radicals through Fenton reaction with hydrogen peroxide (H2O2), which directly reacts with polyunsaturated fatty acids (PUFAs) in cell membranes and plasma membranes to produce massive lipid ROS, Finally leading to cell death . Excess iron ions are stored through the formation of ferritin polymers , and Fe2+ is exported extracellularly through membrane ferroportin (FPN) , thus keeping iron level inside the cell in homeostasis. Ferritin is formed of 24 subunits of ferritin heavy chain 1 (FTH1) and ferritin light chain (FTL), which chelate approximately 4500 iron atoms. It was indicated that increasing ferritin break down or supressing ferritin expression increases intracellular LIP and increases cellular sensitivity to ferroptosis. In contrast, ferritin and its derivatives, and iron chelators helps ferroptosis resistance by decreasing intracellular iron ion levels or inhibiting the activity of several iron-containing metalloenzymes that catalyze lipid peroxidation reactions. SLC40A1-encoded FPN is the only known iron-exporting protein in mammals and is included in the Fe2+ efflux mechanism to maintain iron homeostasis and regulate ferroptosis. Ubiquitin-specific protease 35 (USP35) was discovered to interact directly with FPN and function as a deubiquitinating enzyme to maintain its protein stability. Whereas, USP35 knockdown elevates intracellular LIP levels and induces ferroptosis by reducing FPN-mediated iron export.

Ferroptosis in Autoimmune Hepatitis:

Microarray analysis indicated that ferroptosis may occur in mice with autoimmune hepatitis (AIH). S100-induced autoimmune hepatitis in a mouse model revealed that the knockdown of GPX4 increased the S100-induced accumulation of the lipid peroxide MDA and Fe2+ in liver tissues, hence significantly exacerbating ferroptosis in AIH. Fer-1 is a well-known and commonly used inhibitor of ferroptosis that has been shown to counteract S100-induced autoimmune hepatitis (AIH) and the resulting ferroptosis, thereby diminishing liver damage. This research aims to discover the importance of ferroptosis in immune-mediated hepatitis, suggests its potential role in the progression of autoimmune hepatitis as either an initiator or a mediator, and highlights the promise of targeting ferroptosis to enhance treatment options for JAIH, offering new insights for managing the disease.

02

Conditions studied

  • Autoimmune Hepatitis

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03

In context

Hepatitis, Autoimmune

82 studies on the registry are indexed under Hepatitis, Autoimmune; 24 are open to participants now.

This study's planned enrollment of 60 is below the median of 273 across 36 observational studies indexed under Hepatitis, Autoimmune.

Browse Hepatitis, Autoimmune studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Cases with inadequate tissue in the paraffin block
  2. Children with viral hepatitis
  3. patients above the age of 18 years old
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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

    Time frame: 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

    To know whether ferroptosis is an initiator or mediator in the pathogenesis of juvenile autoimmune hepatitis, the investigators will use Massion's trichrome stain to assess the level of neuroinflammation and extent of fibrosis

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06896383
Lead sponsor
Assiut University
Responsible party
Mariam Mohamed Rashwan Mohamed (Assistant lecturer, Assiut University) — Principal investigator
First posted
Mar 26, 2025
Start date
Nov 2025 (estimated)
Primary completion
Nov 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Mar 26, 2025

Study contacts

Mariam Mohamed Rashwan, bachelor's degree
Contact
Mariam.rashwan@aun.edu.eg
+20 1158056572
Shimaa Hassan Shaban, PhD
Contact
shimaahassan@aun.edu.eg
+20 1090651710
Howadya Ismail Hassan El Sayed, PhD
study director · Assiut University
Moemen Mostafa Ahmed Hafez, PhD
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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