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CTRI Number  CTRI/2025/01/079714 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison of two blood tests for their utility of disease confirmation in patients suffering from a skin disease with multiple blisters. 
Scientific Title of Study   A cross-sectional study comparing BIOCHIP Mosaic 7 and Multivariant ELISA in the serodiagnosis of IgG-mediated Autoimmune Blistering Disorders 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC1: 434/2024 version 1 dated 08.01.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha M Shetty 
Designation  Associate Professor, Department of Dermatology 
Affiliation  Kasturba Medical College Manipal, MAHE 
Address  Kasturba Medical College Manipal Room No. 21, Old OPD Block Department of Dermatology, Kasturba Medical College MAHE, Manipal Madhav Nagar, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9902394514  
Fax    
Email  varsha.shetty@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varsha M Shetty 
Designation  Associate Professor, Department of Dermatology 
Affiliation  Kasturba Medical College Manipal, MAHE 
Address  Kasturba Medical College Manipal Room No. 21, Old OPD Block Department of Dermatology, Kasturba Medical College MAHE, Manipal Madhav Nagar, Udupi


KARNATAKA
576104
India 
Phone  9902394514  
Fax    
Email  varsha.shetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Saurodeep Basu 
Designation  Academic Junior Resident (MD Dermatology) 
Affiliation  Kasturba Medical College Manipal, MAHE 
Address  Kasturba Medical College Manipal Room No. 22, Old OPD Block Department of Dermatology, Kasturba Medical College MAHE, Manipal Madhav Nagar, Udupi

Udupi
KARNATAKA
576104
India 
Phone  7753969467  
Fax    
Email  saurodeep97@rediffmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education(MAHE), Manipal, Madhav Nagar, Udupi, Karnataka - 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba Medical College MAHE, Manipal Madhav Nagar,Udupi Karnataka Pin - 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Varsha M Shetty  Kasturba Medical College Manipal Room No. 21, Old OPD Block, Department of Dermatology, Kasturba Medical College MAHE, Manipal Madhav Nagar, Udupi Udupi KARNATAKA 576104 India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varsha M Shetty  Kasturba Medical College Manipal  Room No. 21, Old OPD Block, Department of Dermatology, Kasturba Medical College MAHE, Manipal Madhav Nagar, Udupi Udupi KARNATAKA 576104 India
Udupi
KARNATAKA 
09902394514

varsha.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee – 1: 434/2024   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L139||Bullous disorder, unspecified, (2) ICD-10 Condition: L10-L14||Bullous disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All treatment naïve, new cases of Pemphigus (and its variants) and Pemphigoid group of diseases diagnosed by immunofluorescence studies (DIF/IIF) or conventional serological methods 
 
ExclusionCriteria 
Details  1. Failure to obtain written informed consent for the study or investigations
2. IgA-mediated autoimmune blistering disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, and positive and negative predictive values of BIOCHIP Mosaic 7 in patients with IgG-mediated autoimmune blistering disorders (AIBD).  At baseline (at the time of diagnosis). 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, & positive & negative predictive values of multivariant ELISA in patients with IgG-mediated AIBD.  At baseline (at the time of diagnosis). 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [varsha.shetty@manipal.edu].

  6. For how long will this data be available start date provided 26-01-2027 and end date provided 26-01-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Autoimmune blistering diseases (AIBD) are characterized by the presence of autoantibodies directed against the major structural proteins in skin and mucous membranes such as the desmosomes and hemidesmosomes. DIF microscopy is considered as the gold standard in the diagnosis of AIBD. However, DIF often provides limited information about the target antigens and the conventional serological diagnosis of IgG mediated AIBD is done by a multi-step approach based on initial indirect immunofluorescence (IIF) microscopy and subsequent individual antigen-specific assays by enzyme-linked immunosorbent assay (ELISA). This shows that the current diagnostic approach in IgG mediated AIBD is a multi-step process which is time consuming resulting in a significant time-lag before a precise diagnosis is made.

A single test that is simple, rapid and minimally invasive is the need of the hour in the diagnosis of IgG mediated AIBD. BIOCHIP is an indirect immunofluorescence technique for the rapid diagnosis of autoimmune blistering conditions. It provides the results of multiple individual tests on a single field. On the other hand, a recently developed multivariant profile ELISA is a single testing strategy where simultaneous processing of multiparametric antigen-specific testing for autoantibodies is possible in adjacent wells of a microplate.

Thus, we intend to undertake the present study as there is paucity of studies from India comparing these two techniques in the diagnosis of IgG mediated AIBD. All newly diagnosed cases of IgG mediated AIBDs, who meet the inclusion criteria will be recruited in the study. A detailed history and examination findings shall be entered in the predesigned proforma. Perilesional skin biopsy sample will be obtained for direct immunofluorescence (DIF) microscopy and serum sample will be obtained for BIOCHIP and multi-variant ELISA. The results obtained shall be compiled and analyzed using standard statistical methods. 

 
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