Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Efficacy of lymphoscintigraphic examination and SLN biopsy
研究概览
简要总结
The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.
详细描述
Patients will undergo:
- Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
- Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
- Injection of 99mTc-labeled nanocolloids
- Preoperative lymphoscintigraphy
- Intraoperative search by gamma probe of the sentinel lymph node
- Sentinel lymph node biopsy
- Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
- In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
- Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous
- •Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, >1 mitotic figure per high-power field.
- •Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.
- •Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion
- •Patients with squamous cell Ca of the surface with Staging ≥3 and/or multicenter
- •Signature of informed consent to participate in the study
排除标准
- •Age less than 18 years
- •Patients with metastatic disease at diagnosis
- •All patients who do not fit the inclusion criteria
- •Failure to obtain informed consent
结局指标
主要结局
Efficacy of lymphoscintigraphic examination and SLN biopsy
时间窗: 9 years
Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
次要结局
- Diseases Free Survival (DFS)(5 years)
- Progression Free Survival (PFS)(5 years)
- Overall survival (OS)(5 years)
- Changes in clinical parameter (tumor diameters)(60 months)
研究者
Savino Gustavo
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS