| CTRI Number |
CTRI/2025/04/084468 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Different Laboratory Tests to Diagnose Autoimmune Blistering Skin Diseases A Pilot Study |
|
Scientific Title of Study
|
To Compare the Utility of Immunofluorescence Techniques [Direct and Indirect Immunofluorescence with Salt-Split Skin Assay], Biochip Mosaic Assay, and Multiplex ELISA in the Diagnosis of Autoimmune Bullous Diseases – A Prospective Cross-Sectional Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujay Khandpur |
| Designation |
Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Dermatology and Venereology,
All India Institute of Medical Sciences,
New Delhi-110029, India
South
DELHI
110029
India |
| Phone |
09818461143 |
| Fax |
|
| Email |
sujay_khandpur@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Rathore |
| Designation |
Junior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Dermatology and Venereology,
All India Institute of Medical Sciences,
New Delhi-110029, India
South
DELHI
110029
India |
| Phone |
9644015606 |
| Fax |
|
| Email |
ankurrathore@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujay Khandpur |
| Designation |
Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Department of Dermatology and Venereology,
All India Institute of Medical Sciences,
New Delhi-110029, India
DELHI
110029
India |
| Phone |
09818461143 |
| Fax |
|
| Email |
sujay_khandpur@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar, New Delhi - 110029
India |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujay Khandpur |
All India Institute of Medical Sciences , Ansari Nagar, New Delhi - 110029 |
Department of Dermatology and Venereology , Room No.4078 ,4th floor , Teaching Block.
South
DELHI |
09818461143
sujay_khandpur@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE ,All INDIA INSTITUTE OF MEDICAL SCIENCES All INDIA INSTITUTE OF MEDICAL SCIENCES OLD OT BLOCK ROOM NO. 102 1ST FLOOR NEW DELHI, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
A total of 10 healthy controls
i.e. patients with non-inflammatory dermatoses,
consenting for skin biopsy and venous blood
sample. |
| Patients |
(1) ICD-10 Condition: L14||Bullous disorders in diseases classified elsewhere, (2) ICD-10 Condition: L11||Other acantholytic disorders, (3) ICD-10 Condition: L13||Other bullous disorders, (4) ICD-10 Condition: L12||Pemphigoid, (5) ICD-10 Condition: L10||Pemphigus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Active cases of autoimmune bullous diseases
(AIBDs), both intraepidermal and subepidermal,
of any age and gender, diagnosed on the basis of
clinical features, histopathological examination
and Immunoblot assay (for detection of specific
antigens).
2.Patients giving consent for participation in the
study and obtaining skin biopsy (lesional and
perilesional normal skin) and venous blood
samples. |
|
| ExclusionCriteria |
| Details |
1.Patients of AIBDs with inactive disease.
2.Patients who are on oral immunosuppressive
therapy other than oral corticosteroids
(≤20mg/day) for past 4 weeks or have received
rituximab in past 6 months.
3.Patients who are transplant recipients or on
chemotherapy, or any major
immunosuppression.
4.Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the utility of
immunofluorescence (IF) techniques (direct
immunofluorescence, indirect immunofluorescence
with salt-split skin assay) in the diagnosis of
autoimmune bullous diseases (AIBDs) |
Baseline Data will be collected and will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of IF techniques
with Biochip mosaic assay & Multiplex ELISA
(Dermatology Profile ELISA) in the diagnosis of
AIBDs |
Baseline Data will be collected & will be assessed every 6 monthly of the study with simultaneous patient recruitment. Final analysis will be done at the end of the study at 24 month |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
20/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
To the best of our knowledge there is paucity of studies
in literature comparing the utility of various
immunofluorescence assays (DIF, IIF with salt-split
skin assay), biochip mosaic assay and serodiagnosis by
Multiplex ELISA test in the diagnosis of AIBDs.
We will be comparing the sensitivity, specificity,
positive predictive value and negative predictive value
of all these assays in the diagnosis of AIBDs Study design: Prospective cross-sectional pilot study.
Duration of study: 2 years Jan 2025 from to Jan 2027)
Number of patients: At least 50 cases and 35 controls
will be recruited. We will be recruiting total of 35 controls in the project
Disease controls – 25
Healthy controls – 10
All patients attending the out-patient department of
Dermatology and Venereology, All India Institute of
Medical Sciences, New Delhi, will be screened for
active cases of AIBDs (both intraepidermal and sub
epidermal), for recruitment into the study.
Control patients (both diseased and healthy controls)
will also be recruited.
Cases- Skin biopsy samples and sera of at least 50
confirmed (combination of clinical, histopathological
features and IB assay) cases of active AIBDs (both
intraepidermal and subepidermal diseases), will be
subjected to immunofluorescence assays (DIF, IIF with
salt-split skin assay), Biochip mosaic assay and
Multiplex ELISA.
The diagnosis of AIBD will be confirmed on the basis
of clinical features, histopathological examination, and
immunoblot assay.
Definitive diagnosis - Immunoblot assay, clinical
assessment and histopathological examination- all three
are positive.
Probable diagnosis – Clinical and histopathological
examination are positive
Cases will be taken on the basis of probable diagnosis
initially for the recruitment |