| CTRI Number |
CTRI/2025/09/094377 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of spectrum of skin biopsies at tertiary care hospital |
|
Scientific Title of Study
|
A study of histopathological spectrum of skin biopsies at tertiary care hospital |
| 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 Rutu Patel |
| Designation |
1st year resident |
| Affiliation |
Dr. N D Desai faculty of medical science and research |
| Address |
Department of pathology,Dr. N D Desai medical college, Nadiad. Dharamsinh desai university, college road, Nadiad Kheda GUJARAT 387001 India |
| Phone |
7383573840 |
| Fax |
|
| Email |
rutumpatel10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Parth bhatt |
| Designation |
Associate professor |
| Affiliation |
Dr. N D Desai faculty of medical science and research |
| Address |
Department of pathology, Dr. N D Desai medical college, Nadiad. Dharamsinh desai university, college road, Nadiad Kheda GUJARAT 387001 India |
| Phone |
7383573840 |
| Fax |
|
| Email |
parthbhatt.medical@ddu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Rutu Patel |
| Designation |
1st year resident |
| Affiliation |
Dr. N D Desai faculty of medical science and research |
| Address |
Department of pathology,Dr. N D Desai medical college, Nadiad. Dharamsinh desai university, college road, Nadiad Kheda GUJARAT 387001 India |
| Phone |
7383573840 |
| Fax |
|
| Email |
rutumpatel10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. N D Desai faculty of medical science and research |
| Address |
Dharamsinh desai university,College road, Nadiad |
| Type of Sponsor |
Private 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 Rutu Patel |
Dr. N D Desai faculty of medical science and research |
Room no 157, Department of pathology,Dharamsinh desai university, College road, Nadiad. Kheda GUJARAT |
7383573840
rutumpatel10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr. N D Desai faculty of medical science and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients having dermatological diseases diagnosis of which is required and done by histopathology. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| As no intervention is done in my study, outcome will not be measured. |
As no intervention is done in my study, time point will not be measured. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
01/10/2025 |
| 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 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
|
While many of skin lesions many present with overlapping clinical features, accurate diagnosis is crucial for distinct treatments for its effectiveness. Therefore, performing histopathological examination through biopsy remains the gold standard for definitive diagnosis and guide appropriate therapy. |