| CTRI Number |
CTRI/2025/01/079700 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Series |
| Study Design |
Other |
|
Public Title of Study
|
Case studies of patient who took Tab Ribociclib and Palbociclib and have suffered vitiligo complaint |
|
Scientific Title of Study
|
A case series to report CDK4/6 induced Vitiligo. |
| 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 Sudeep Gupta |
| Designation |
Director TMC and Professor Medical Oncology |
| Affiliation |
Tata Memorial Center |
| Address |
Room no: 1109, 11 floor,
Homi Bhabha Building
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
|
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Gupta |
| Designation |
Director TMC and Professor Medical Oncology |
| Affiliation |
Tata Memorial Center |
| Address |
Room no: 1109, 11 floor,
Homi Bhabha Building
Tata Memorial Hospital
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
|
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Yogesh Kembhavi |
| Designation |
Research Manager |
| Affiliation |
Tata Memorial Center |
| Address |
Room no: 1109, 11 floor,
Homi Bhabha Building
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09967594597 |
| Fax |
|
| Email |
yogeshkembhavi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMC: Research Administration And Council
Tata Memorial Centre.
3rd floor, Main building
E Borges Marg
Parel
400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
E Borges Marg
Parel,
Mumbai 400012
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
NA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudeep Gupta |
Tata Memorial Hospital |
Room no: 106,
1st floor,
Homi Bhabha Building
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA |
02224177201
sudeepgupta04@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Hormone positive, HER 2 negative breast cancer patients, who are receiving CDK4/6 inhibitors. |
|
| ExclusionCriteria |
| Details |
Not willing participants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Main study: The purpose of the study is to report the adverse event Vitiligo in patients taking CDK4/6 inhibitor. The optional part: The aim of this study is to dermatologically define and histologically characterize this drug induced vitiligo. |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
00 |
|
|
Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
15/02/2025 |
| 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="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
|
Study Methodology: This is an observational study of patients, who are currently on CDK4/6 inhibitors, i.e. Tab Ribociclib or Tab Palbociclib. Patients will be consented for the study, during their routine follow-up visit. Photographic images will be taken for the records. No treatment interventions will be done. Patient’s demographic and medical history will be noted, to study any common correlations among the reported cases if any. The second optional part of the study will be to acquire biopsy from the vitiligo affected area. It will be taken from patients, who will consent for it. Biopsy will be an optional procedure, and denying it will not affect the main study enrollment. A separate ICF will be used for consenting from patients who will be willing for the skin biopsy. Punch biopsy will be done from hypopigmented patches and subjacent healthy skin. Loss of Melanin pigment will be graded as partial or complete as opposed to adjacent normal skin. Number of melanocytes will be counted in basal later using immunohistochemistry. Any inflammatory reaction around the dermal melanocytes or in dermis will also be studied. Any epidermal changes will also be studied. |