Galectin-3 and PemphigusNCT05992727
Evaluation of Galectin-3 in Serum and Saliva of Pemphigus Patients
An observational study of Galectin-3 and Pemphigus, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Galectin-3 and Pemphigus
- What is being tested?
- Galectin 3 measurement in serum and saliva by ELIZA
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients with active stage of pemphigus.
Who cannot join
- Patients who were on topical ttt, systemic corticosteroids or other immunosuppressive drugs in the last one month.
- Patients with disease attack duration more than 1 week.
- Patients with any other concomitant dermatological or chronic systemic diseases.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Galectin 3 Level in Serum and Saliva of Pemphigus Patients and Its Correlation With Disease Severity and Systemic Comorbidities
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).
Read the detailed description
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
- Galectin-3 and Pemphigus
- Being tested
- Galectin 3 measurement in serum and saliva by ELIZA
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galectin 3 measurement in serum and saliva by ELIZADiagnostic test
Also called complete blood count,renal function tests, random blood sugar,urine analysis and echocardiography
Galectin 3 measurement in serum and saliva by ELISA in the two groups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Galectin 3 measurement in serum and saliva by ELIZA | |
| Group 2( controls) | Galectin 3 will be measured in30 age and sex matched healthy controls Receives: Diagnostic Test: Galectin 3 measurement in serum and saliva by ELIZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start8 Aug 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Galectin-3 and PemphigusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Fathy Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992727
- Sponsor's protocol ID
- Galectin -3 and pemphigus
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33767069
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Galectin 3 Level in Serum and Saliva of Pemphigus Patients and Its Correlation With Disease Severity and Systemic Comorbidities
- ClinicalTrials.gov ID
- NCT05992727
- Acronym / sponsor ID
- Galectin -3 and pemphigus
- Conditions
- Galectin-3 and Pemphigus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Aug 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1( cases) | – | Diagnostic Test: Galectin 3 measurement in serum and saliva by ELIZAGalectin 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. |
| Group 2( controls) | – | Diagnostic Test: Galectin 3 measurement in serum and saliva by ELIZAGalectin 3 will be measured in30 age and sex matched healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients with active stage of pemphigus.
Key exclusion criteria (4 listed)
- Patients who were on topical ttt, systemic corticosteroids or other immunosuppressive drugs in the last one month.
- Patients with disease attack duration more than 1 week.
- Patients with any other concomitant dermatological or chronic systemic diseases.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galectin 3 measurement in serum and saliva by ELIZAAlso: complete blood count,renal function tests, random blood sugar,urine analysis and echocardiographyGalectin 3 measurement in serum and saliva by ELISA in the two groups | Diagnostic test | Group 1( cases), Group 2( controls) |
Primary outcome
Assessment of Galectin 3
Time frame: 1 year
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.
Develop a novel biomarker in serum and saliva of pemphigus patients and to detect its correlation with disease activity, as well as systemic comorbidities.
Time frame: 1year
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Results publication: PubMed 33767069Aghighi 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Galectin-3 and Pemphigus, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Fathy, MD (+201002258614, emanfathy639@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Galectin 3 (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.