An observational study in Galectin-3 and Pemphigus, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by Assiut University · Observational
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).
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.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 21 observational studies indexed under Pemphigus.
Browse Pemphigus studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
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Pemphigus patients in active stage either newly diagnosed or in a relapse. The diagnosis of each patient is based on clinical examination , histopathological examination and direct immunofluorescence.
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.
Patients with active stage of pemphigus.
Exclusion Criteria:
Patients with any other concomitant dermatological or chronic systemic diseases.
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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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Galectin 3 measurement in serum and saliva by ELIZA
Galectin 3 will be measured in30 age and sex matched healthy controls
Diagnostic Test: Galectin 3 measurement in serum and saliva by ELIZA
Galectin 3 measurement in serum and saliva by ELISA in the two groups
Also known as: complete blood count,renal function tests, random blood sugar,urine analysis and echocardiography
Assessment of Galectin 3
Three millimeters of blood will be withdrawn aseptically from all patients and controls from the antecubital vein using disposable plastic syringe. The sera will be separated and stored at -20 C. Saliva will be collected from patients and controls after asking them to refrain from eating and drinking (except for water) for 2 hours before collection. Then, they will be asked to rinse their mouth with water, tilt their heads down, pool saliva in the mouth for 1 minute, drool into a sterile falcon tube. Saliva will be separated and stored also at-20 C. Human Gal-3 ELISA kit will be used for quantitative measurement of serum and saliva Gal-3 levels. The assay will be performed according to the manufacturer's instructions.
Time frame: 1 year
Develop a novel biomarker in serum and saliva of pemphigus patients and to detect its correlation with disease activity, as well as systemic comorbidities.
All patients will be subjected to complete history taking, meticulous general, dermatological examination and routine investigations. Echocardiography, kidney function tests and urine analysis will be conducted for all the participants. Disease severity will be assessed by ABSIS score with a maximum score of 206. It uses the rule of 9s to assess the percentage of involvement of blisters and erosions on the skin combined with a weighting factor for the stage of the blistering and erosions. Oral involvement is based on 2 scores comprising the extent (presence of lesions) and severity (discomfort during eating and drinking)
Time frame: 1year
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This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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