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临床试验/NCT06196190
NCT06196190招募中不适用

The Prognostic Value of Conization and Negative HPV Typing After Conization Prior to Surgical Intervention in Adenocarcinoma in Situ and Early Stage Cervical Cancer

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Final Pathology

研究概览

简要总结

In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma,

Adeno-squamous carcinoma or AIS we want to examine prospectively:

  1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumor in the final pathology.
  2. To examine if conization in women with cervical tumor up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.

详细描述

The treatment of invasive cervical cancer is tailored according to the FIGO recommendations. The standard treatment for women with early-stage, (IA2-IB1) cervical cancer is simple or Radical Hysterectomy (RH) and in women with Adenocarcinoma in Situ hysterectomy is recommended when they finish their fertility program .A Few studies describe that conization before Radical Hysterectomy in women with cervical cancer stage I B 1 ( tumour up to 4 cm according to FIGO 2009 ) , are in correlation with better prognosis , Bizzari describe women that had conization before RH had better 5 year survival. Uppal report that those women have less recurrence, OR of 0.4 compared with women without conization. Chacon summarize SUCCOR study, a multi center study that collected data about 374 women with cervical cancer Stage I B 1 according to FIGO 2009 -tumour up to 4 cm .187 women had conization before RH and 187 had RH without conization. Women that had conization had 65% less recurrence 'and 75% les mortality.

Several studies have explored the possibility of a less aggressive approach for cervical cancer patients with low-risk early-stage disease who wish to preserve fertility. The parameters that were investigated were: the depth of invasion, tumour diameter, lymph node status positive margins in conization, positive Endo Cervical Curettage (ECC) and lymph-vascular space invasion. Those parameters have a low sensitivity and between 50-65% of women who had RH had no residual tumour in the final pathology.

Schmeler describe that woman who had conization before RH in 97.5% had no residual tumour.

A study of 92 women with cervical cancer and Adeno Carcinoma In situ (AIS) that short time after conization were negative to High-Risk HPV (HR-HPV) they had before the conization in 95% there was no residual tumour in the final pathology, or during the follow up.

To our knowledge there is no prospective study that examined the the prognostic value of Conization and negative HR- HPV typing after Conization prior to surgical intervention in Early-Stage Cervical Cancer and Adenocarcinoma in Situ.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age Range: 18-85 years old Cervical cancer stage I B 2(Tumor up to 4 cm FIGO 2018) AIS HPV types before and after conization

排除标准

  • Pregnant women under 18 years old. Women who refused to continue to be in study. Women that data about HPV types , final pathology or complication are missing.

结局指标

主要结局

Final Pathology

时间窗: 1 year

Residual disease in final pathology

次要结局

  • Mortality(5 year)
  • Disease recurrence(5 year)
  • complications(5 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yoav Siegler B.Sc. M.D

Resident at the Gynecological Oncology Department

Rambam Health Care Campus

研究点 (1)

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