Can the Investigators Extend the Indication for Sentinel Node Biopsy in Vulvar Cancer? A Nationwide Feasibility Study From Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Detection rate and negative predictive value for sentinel node biopsy
研究概览
简要总结
The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.
详细描述
PRIMARY OBJECTIVES:
This study is primarily a pilot and feasibility trial, aiming to evaluate if sentinel node biopsy has a satisfactory detection rate and negative predictive value in certain groups of vulvar cancer patients.
OUTLINE:
The study is planned as a prospective, multi-center cohort study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.
Eligible patients will undergo a sentinel node biopsy additionally to their radical inguinofemoral lymphadenectomy and detection rate and negative predictive value for the sentinel procedure will be calculated. The study will consist of four patient groups: Patients with squamous cell vulvar cancer and:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with squamous cell vulvar cancer and
- •primary tumors ≥ 4cm
- •multifocal primary tumors
- •local recurrence, earlier no treatment of the groins or only sentinel node biopsy
- •local recurrence, earlier treatment of the groins with radiotherapy / inguinofemoral lymphadenectomy
- •≥ 18 years of age
- •Considered clinically appropriate for surgery
- •Informed consent
排除标准
- •Eastern Cooperative Oncology Group performance status > 2
- •Disability to read or write in Swedish
- •Dementia / severe psychiatric illness leading to disability to understand the study / study information
- •Signs of inguinal lymph node or distant metastases
- •Ongoing pregnancy
结局指标
主要结局
Detection rate and negative predictive value for sentinel node biopsy
时间窗: 2019-2021
Calculated for each group separately. Per groin and per patient.
次要结局
- Proportion of micrometastases and isolated tumor cells, diagnosed by ultra-staging in relation to routine-histopathological examination(2019-2021)
- Number of retrieved sentinel lymph nodes(2019-2021)
研究者
Diana Zach
Principal Investigator
Karolinska University Hospital