跳至主要内容
临床试验/NCT03622983
NCT03622983招募中不适用

Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

Centre Hospitalier Intercommunal Creteil2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2017年5月1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
500
试验地点
2
主要终点
circulating tumor and DNA

研究概览

简要总结

The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

详细描述

The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients.

Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.

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

入选标准

  • Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence;
  • Or diagnosis of endometriosis on histology or imaging
  • Age ≥ 18 years;
  • Affiliation to the general social security scheme;
  • Consent signed.

排除标准

  • Refusal of the patient;
  • Non-affiliation to the general social security scheme.

结局指标

主要结局

circulating tumor and DNA

时间窗: 2 years

Endometriosis tumor and DNA

时间窗: 2 years

次要结局

  • circulating Micro RNA(10 years)
  • circulating tumor DNA(10 years)
  • circulating cytokines(10 years)
  • Tumoral DNA(day of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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