| CTRI Number |
CTRI/2021/12/039007 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of skin and biopsy features in children with Langerhans cell histiocytosis |
|
Scientific Title of Study
|
A cross-sectional descriptive study to characterize the cutaneous and histological features in children with Langerhans cell histiocytosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avik Mondal |
| Designation |
Junior Resident |
| Affiliation |
ALL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Skin OPD, RN 313, 3rd floor, Rajkumari Amrit Kaur OPD
New Delhi
DELHI
110029
India |
| Phone |
07908072776 |
| Fax |
|
| Email |
avik.mondal11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetu Bhari |
| Designation |
Associate Professor |
| Affiliation |
ALL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Teaching block, RN 4078A, 4th floor, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
07908072776 |
| Fax |
|
| Email |
drntbhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avik Mondal |
| Designation |
Junior Resident |
| Affiliation |
ALL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Skin OPD, RN 313, 3rd floor, Rajkumari Amrit Kaur OPD
New Delhi
DELHI
110029
India |
| Phone |
07908072776 |
| Fax |
|
| Email |
avik.mondal11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ANSARI NAGAR, NEW DELHI |
| Type of Sponsor |
Government medical college |
|
|
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 Avik Mondal |
All India Institute of Medical Science |
Skin opd, RN 313, Rajkumari Amrit Kaur OPD, 3rd floor, AIIMS
New Delhi
DELHI |
7908072776
avik.mondal11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with clinical and histological diagnosis of Langerhans cell histiocytosis |
|
| ExclusionCriteria |
| Details |
1. Children with a doubtful diagnosis of Langerhans cell histiocytosis
2. Parents not willing to participate in this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Description of clinical and histological features in children with Langerhans cell histiocytosis |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of these clinical and histological features with frequency and severity of systemic involvement in children with Langerhans cell histiocytosis |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
03/01/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Langerhans
cell histiocytosis is a clonal proliferative disorder of histiocytes characterized
by accumulation of CD1a + Langerhans cells in various organs. There is a scarcity of information regarding
various cutaneous and histological presentations of this disease. Some studies
have indicated a prognostic role of few cutaneous and histological findings of Langerhans
cell histiocytosis. Thus, this study will aim to describe the clinical and
histological findings of this condition and their correlation with frequency
and severity of systemic involvement. |