Predicting the Presence of Histologic Criteria for Adjuvant Post-operative Radiation of Patients With Cervical Cancer Stage IB2 by Large Loop Biopsy Prior to Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The rate of LVSI in Cervix cancer
研究概览
简要总结
A pre- operative evaluation for the presence of intermediate risk factors prior to surgery may allow for better patient counselling, modify the course of surgery or select patients to undergo primary chemo- radiation.
The purpose of this study is to validate that the presence of histological risk factors in a pre-operative large loop biopsy highly correlates with post-operative histological evaluation and the subsequent indication for post-operative chemo-radiation
详细描述
Patients with cervical cancer who are scheduled for radical hysterectomy and underwent a pre- operative MRI and PET- CT that have demonstrated a tumor ≥2- 4cm cm and the absence of nodal metastasis on imaging will be offered to give consent and participate.
After anesthesia and immediately prior to surgery, the surgeon will perform a large loop biopsy of depth of 1.5 and a diameter of 1.0 cm from the cervical tumor. Hemostasis can be achieved by the usual measures or by packing. Surgery will follow immediately as planned.
In patient who in the course of the preoperative evaluation underwent large loop biopsy histologic analysis of this biopsy will be performed similarly. If the large loop specimen is appropriate (>1.5X1cm) and allows assessment of all the histologic risk factors, no repeat large loop biopsy will be performed.
In patient that the that the previous large loop biopsy is not be appropriate for complete histologic analysis and the surgeon asses that a repeat biopsy is technically feasible, a large loop biopsy will be performed prior to the radical hysterectomy as described above.
All histological evaluation will be carried out as usual in hospital in which the surgery was performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with cervical cancer who are scheduled for radical hysterectomy and underwent a pre- operative imaging (MRI and PET CT) that have demonstrated a tumor ≥2-4 cm and the absence of nodal metastasis.
- •Pre -operative assessment by the surgeon that a large loop biopsy of depth of 1.5 and a diameter of 1 cm is technically feasible.
- •Patient who in the course of the preoperative evaluation underwent large loop biopsy of depth of 1.5 and a diameter of 1.0 cm, and in the subsequent evaluation fulfilled the criteria in (1).
排除标准
- •Patient who do not sign the informed consent. Patient who is scheduled for Chemoradiation Patients with large loop biopsy which is smaller than depth of 1.5 and a diameter of 1.0 cm
结局指标
主要结局
The rate of LVSI in Cervix cancer
时间窗: two years
Pre operative presence of LVSI in loop biopsy in cervical cancer, compared to post operative LVSI rate in hysterectomy Specimen
次要结局
未报告次要终点
研究者
Alon Ben Arie
Director of obstetrics and gynecology department
Kaplan Medical Center