A case series to report CDK4/6 induced Vitiligo.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Hormone positive, HER 2 negative breast cancer patients, who are receiving CDK4/6 inhibitors.
排除标准
- •Not willing participants.
结局指标
主要结局
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.
时间窗: 3 MONTHS
次要结局
- Not applicable(00)
研究者
Dr Sudeep Gupta
Tata Memorial Center
