Basal Cell Carcinoma Follow Up Study. A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Basal Cell Carcinoma growth from Baseline
研究概览
简要总结
The purpose of this study is to find out more about how Basal Cell Carcimonas/BCCs grow and to learn more effective ways to monitor and treat these common cancers. This study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •Diagnosed with at least 1 BCC based on clinical, dermoscopy, RCM and OCT
- •Patients with BCCs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 BCC, which would require removal of the BCC.
- •Patients with BCCs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of OCT imaging (0.8mm)
- •Treatment naiive lesions
- •Ability to sign informed consent
排除标准
- •Immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by AIDS, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, CLL, aspelenia, and pregnancy).
- •Patients with cancer genetic syndromes that increase risk of BCC (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis).
- •Patients with BCCs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative BCCs.
- •Patients with BCCs that have a diameter larger than 1.5cm\
- •Patients with BCCs that have a depth greater than 0.6mm
- •Patients with BCCs in high risk locations, i.e. "H" area of the face. (is located in the mid-face at the site of the embryologic fusion plates and is generally believed to be associated with more aggressive skin cancers).
- •Patients with BCCs on locations that may compromise an organ function should the tumor enlarge (for example, eyelid).
- •Tumor located on a site that precludes attachment of the RCM device or inability to tolerate imaging procedure (i.e. remain relatively still for multiple short durations of 3- 4 minutes over a total time of 20-30 minutes)
- •Lesions that previously received therapeutic intervention
- •Inability to give informed consent
研究组 & 干预措施
Participant with Basal Cell Carcinoma/BCC
Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography)
干预措施: Digital Dermoscopy (Diagnostic Test)
Participant with Basal Cell Carcinoma/BCC
Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography)
干预措施: Reflectance confocal microscopy (RCM) (Diagnostic Test)
Participant with Basal Cell Carcinoma/BCC
Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography)
干预措施: Optical coherence tomography (OCT) (Diagnostic Test)
Participant with Basal Cell Carcinoma/BCC
Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography)
干预措施: Dermtech tape-stripping (Diagnostic Test)
Participant with Basal Cell Carcinoma/BCC
Participants have been diagnosed with at least 1 Basal Cell Carcinoma/BCC based on clinical, dermoscopy, RCM (reflectance confocal microscopy) and OCT (optical coherence tomography)
干预措施: Total Skin Examinations (Diagnostic Test)
结局指标
主要结局
Change in Basal Cell Carcinoma growth from Baseline
时间窗: 3 years
To adequately measure the growth dynamics of tumors, several imaging modalities will be employed. Longest dimension (millimeters) of the lesion from clinical imaging will be the primary measurement of horizontal extent of the lesion. Maximum lesion depth (millimeters) from OCT imaging will be the primary measured of vertical extension.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: up to 3 years
To evaluate the feasibility of active follow-up of BCC as a way of managing BCC.
次要结局
未报告次要终点