OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 11
- 主要终点
- Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors
研究概览
简要总结
Retrospective and prospective multi-center study
Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility
Objectives:
- Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
- Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
Origin and nature of the specific data:
- Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
- Collection of retrospective further informations in the participating centers
- Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .
Data traffic :
TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.
The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.
Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with history of Borderline Ovarian Tumor (BOT).
- •Women who have had first a fertility-sparing surgery.
- •Women old enough to procreate (= 45 years) during their first surgery.
- •Women having agreed to participate in the previous study "Observatoire sur les Tumeurs Malignes Rares de l'Ovaire" (TMRO).
- •Women who have not expressed their opposition to the research.
排除标准
- •The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).
结局指标
主要结局
Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors
时间窗: December 2018
Univariate and multivariate analysis on patients modalities of care and fertility , through medical history and questionnaires (study based on patients who were included in the previous study "Observatoire Sur Les Tumeurs Malignes Rares de l'Ovaire" (TMRO french network)
次要结局
- Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics(December 2018)