A STUDY OF THE CLINICOEPIDEMIOLOGICAL AND HISTOPATHOLOGICAL FEATURES OF EPIDERMAL KERATINOCYTIC NEOPLASMS WITH THE ROLE OF PHOTODYNAMIC THERAPY IN TREATMENT AT A TERTIARY CARE CENTRE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Study of clinicoepidemiologic and histopathologic features of epidermal keratinocytic neoplasms .
研究概览
简要总结
Patient presenting with complaints of suspected tumors like lesion will be advised biopsy and clinical photography will be done. The histopathology report of biopsy will be studied and patients having epidermal keratinocytic tumors like seborrheic keratosis, basal cell carcinoma, squamous cell carcinoma, actinic keratosis, bowenoid papulosis , bowens disease etc will be taken for primary objective which is study of clinicoepidemiologic and histopathological features of epidermal keratinocytic tumors. Patients fulfilling inclusion criteria for secondary objective will be advised photodynamic therapy . The lesion depending on size or location will be either directly or first reduced with a CO2 laser or by shave excision and then photosensitiser will be applied which is 5-aminolevulanic acid and kept covered for 3hrs . Then the area will be irradiated by 630nm light by the photodynamic therapy. Post procedure care will be done for the patient . Patient will be followed up and 2nd session will be done at 2-4 weeks interval depending on tresponse and side effects . After 2 session the result will be evaluated in terms of terms in size of lesion and the side effects if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •For primary objective of clinicoepidemiologic and histopathologic study of epidermal keratinocytic neoplasms- people of any age and gender having clinically suspected tumors For secondary objective of treatment with photodynamic therapy willing for procedure having biopsy proven epidermal keratinocytic neoplasms.
排除标准
- •For primary objective.
- •not willing for biopsy or photography For secondary objective.
- •pregnant and lactating women, less than 18yrs age , people having cardiac disease, porphyria , keloidal tendency, photosensitivity, tumor more than 3cm size ,.
结局指标
主要结局
Study of clinicoepidemiologic and histopathologic features of epidermal keratinocytic neoplasms .
时间窗: Patient will be advised biopsy at presentation and followed up with histopathology report Primary objective is just observational and does not require further follow up unless the patient is taken for secondary objective which is photodynamic therapy
The patients age , gender , occupation, history clinical features , types of lesions , sytemic examination
时间窗: Patient will be advised biopsy at presentation and followed up with histopathology report Primary objective is just observational and does not require further follow up unless the patient is taken for secondary objective which is photodynamic therapy
次要结局
- Safety and efficacy of photodynamic therapy in treatment of epidermal keratinocytic tumors will be seen by doing photodynamic therapy on patient filling inclusion criteria.(A photosensitiser will be applied on the lesion and kept for 3hrs after which the area will be irradiated by light of 630nm from the photodynamic therapy machine)
研究者
Dr Shriya Singh
Grant Government Medical College and Sir JJ hospital