| CTRI Number |
CTRI/2022/09/045833 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An evaluation of the successful excision of black mole using dermoscope. |
|
Scientific Title of Study
|
A prospective evaluation of dermoscopic findings before and after shave excision of melanocytic nevi, in patients seeking mole removal. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shriya Sirohiya |
| Designation |
Post graduate (JR1) |
| Affiliation |
KASTURBA MEDICAL COLLEGE, Mangalore |
| Address |
Department Of Dermatology, Venereology And Leprosy,
Room Number: 10, First Floor, Kmc Hospital Attavar,
Kasturba Medical College,
Mangalore
Kasturba Medical College,
Light House Hill Road,
Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9971474997 |
| Fax |
|
| Email |
shriya.sirohiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar |
| Designation |
Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE, Mangalore |
| Address |
Department Of Dermatology, Venereology And Leprosy,
Room Number: 10, First Floor, Kmc Hospital Attavar,
Kasturba Medical College,
Mangalore
Kasturba Medical College,
Light House Hill Road,
Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845164946 |
| Fax |
|
| Email |
kumar.pramod@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriya Sirohiya |
| Designation |
Post graduate (JR1) |
| Affiliation |
KASTURBA MEDICAL COLLEGE, Mangalore |
| Address |
Department Of Dermatology, Venereology And Leprosy,
Room Number: 10, First Floor, Kmc Hospital Attavar,
Kasturba Medical College,
Mangalore
Kasturba Medical College,
Light House Hill Road,
Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9971474997 |
| Fax |
|
| Email |
shriya.sirohiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
Mangalore |
|
|
Primary Sponsor
|
| Name |
DR SHRIYA SIROHIYA |
| Address |
DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY,
KASTURBA MEDICAL COLLEGE,
MANGALORE |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shriya Sirohiya |
Government Wenlock Hospital, Mangalore |
Department Of Dermatology, Venereology And Leprosy,
Room Number: 34, First Floor, Government Wenlock Hospital,
Mangalore
Dakshina Kannada
KARNATAKA |
9971474997
shriya.sirohiya@gmail.com |
| DR Shriya Sirohiya |
KMC HOSPITAL ATTAVAR |
Department Of Dermatology, Venereology And Leprosy,
Room Number: 10, First Floor, Kmc Hospital Attavar,
Kasturba Medical College,
Mangalore
Dakshina Kannada
KARNATAKA |
9971474997
shriya.sirohiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KASTURBA MEDICAL COLLEGE,MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of age 18 years and above.
2)Patients presenting with clinical features of Melanocytic nevi (who fit into the definition of melanocytic neoplasia) will be included in the study.
3)Patients who voluntarily request for the removal of the Melanocytic nevi.
4)Moles of size not more than 1 cm.
5)Patient who are willing to give informed written consent for enrollment into the study.
|
|
| ExclusionCriteria |
| Details |
1)Patients who are not willing to give consent.
2)Irritated, infected or complicated melanocytic nevi.
3)Other causes of hyperpigmented macules and papules that do not fit into the definition of melanocytic nevi like seborrheic keratoses, ephelides, lentigines, melanoma, basal cell carcinoma, hemangioma, angioma angiokeratoma.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate dermoscopic findings of melanocytic nevi before shave excision and after healing of the excised site, in subjects seeking mole excision. |
1. Baseline
2. Post excision at(0-2 WEEKS)
3. Follow up at (12 WEEKS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and correlate the clinical features of melanocytic nevi with its dermoscopic findings.
2.To analyze dermoscopic findings of melanocytic nevi before and after shave excision.
3.To evaluate prognosis of melanocytic nevi after shave excision.
4.To examine and correlate histopathology of excised nevi with their dermoscopic findings. |
1. Baseline
2. Post excision at(0-2 WEEKS)
3. Follow up at (12 WEEKS) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/09/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dermoscopy is a non-invasive OPD procedure. Histopathological findings will add to diagnose accurately. This study will help us gain about the clinical and dermoscopic finding in melanocytic nevi before and after shave excision that may eventually reveal predictors of recurrence after shave biopsy. Our data can then be useful in clinical scenarios when deciding which nevi patient and lesions should be considered for the surgical excision and counsel the patients accordingly who especially come for the aesthetic reason of mole removal. |