Evaluation of Galectin-3 in Serum and Saliva of Pemphigus Patients

NCT ID: NCT05992727

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-08

Study Completion Date

2024-03-01

Brief Summary

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Assessment of the expression of galectin-3 in serum and saliva of pemphigus patients and compare it with age and sex matched controls. We want to detect whether a correlation exists between galectin-3 level in serum, as well as saliva and disease activity score by Autoimmune Bullous Skin Disorder Intensity Score (ABSIS).

Detailed Description

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Pemphigus is a potentially life- threatening immune mediated bullous disease that affects the skin and mucous membranes with a significant impact on quality of life (1). It is due to production of autoantibodies against desmogleins (adhesion molecules of the epidermis) leading to disruption of junctions between keratinocytes and subsequently acantholysis (2).

Pemphigus diseases are classified based on the clinical, histopathological features, as well as on the specific antigens against which the autoantibodies are produced. The main forms are pemphigus vulgaris (PV) and pemphigus folia¬ceus (PF), but other non-classical forms of pemphigus have also been described as paraneoplastic pemphigus, pemphigus herpetiformis, and IgA pemphigus (3). PV is the main clinical form of pemphigus, accounting for approximately 70% of cases; it is also considered the most severe form of the disease (4).

IgG is the main immunoglobulin seen along the dermal-epidermal junction in pemphigus patients, in addition most patients generate IgE autoantibody response. Soluble CD23 and galectin-3 are the two main elements of the IgE (5).

Galectin-3(Gal-3) is a beta galactoside-binding lectins that is essential in the cell-to-cell or matrix adhesion, as well as plays an important role in cell growth, differentiation, macrophage activation, antimicrobial activity, angiogenesis, and apoptosis. It broadly exists in the nucleus and cytoplasm of various cell types or may be found extracellularly on the cell surface (6) .Gal-3 is readily secreted to the cell surface and into biological fluids as serum, urine, tears and saliva from injured and inflammatory cells. So, it can be used as a sensitive diagnostic or prognostic biomarker for various pathological conditions (7).

Gal-3 has been used as a novel biomarker in the early detection of myocardial dysfunction and heart failure. Many cardiac biomarkers which reflect cardiac inflammation and fibrosis may also contribute to the progression of kidney disease (8, 9) A previous study reported a significant decrease in galectin-3 cytoplasmic and nuclear expression around blisters compared with adjacent unaffected skin in PV, which may play a role in extension of acantholysis (5). To the best of our knowledge, no previous studies assessed the role of Gal-3 in serum or saliva of pemphigus patients.

Conditions

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Galectin-3 and Pemphigus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1( cases)

Galectin 3 will be measured in 30 Patients who are with active stage of pemphigus either newly diagnosed or in a relapse. The diagnosis of each patient is based on clinical examination and histopathological examination.

Galectin 3 measurement in serum and saliva by ELIZA

Intervention Type DIAGNOSTIC_TEST

Galectin 3 measurement in serum and saliva by ELISA in the two groups

Group 2( controls)

Galectin 3 will be measured in30 age and sex matched healthy controls

Galectin 3 measurement in serum and saliva by ELIZA

Intervention Type DIAGNOSTIC_TEST

Galectin 3 measurement in serum and saliva by ELISA in the two groups

Interventions

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Galectin 3 measurement in serum and saliva by ELIZA

Galectin 3 measurement in serum and saliva by ELISA in the two groups

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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complete blood count,renal function tests, random blood sugar,urine analysis and echocardiography

Eligibility Criteria

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Inclusion Criteria

Patients with active stage of pemphigus.

Exclusion Criteria

1. Patients who were on topical ttt, systemic corticosteroids or other immunosuppressive drugs in the last one month.
2. Patients with disease attack duration more than 1 week.
3. Patients with any other concomitant dermatological or chronic systemic diseases.

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Eman Fathy Ahmed

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Eman Fathy, MD

Role: CONTACT

+201002258614

Heba Hasan, MD

Role: CONTACT

+201002866919

References

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Aghighi M, Pukhalskaya T, Smoller BR. Immunohistochemical Expression of Galectin-3 in Pemphigus Vulgaris. Am J Dermatopathol. 2021 Dec 1;43(12):e165-e168. doi: 10.1097/DAD.0000000000001939.

Reference Type RESULT
PMID: 33767069 (View on PubMed)

Other Identifiers

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Galectin -3 and pemphigus

Identifier Type: -

Identifier Source: org_study_id

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