| 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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varsha.shetty@manipal.edu].
- 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.
- 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. |