Impact of Endotest on Patients' Quality of Life: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ZIWIG
- 入组人数
- 20,000
- 试验地点
- 7
- 主要终点
- To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
研究概览
简要总结
Ziwig Endotest® ('Endotest') is marketed in several countries, including Switzerland, which was the first country to make it available in 2022. Since February 2025, several French clinical investigation sites have been offering Endotest, developed by Ziwig, under the innovation funding. Initially, this innovation funding enabled 2,500 patients to be included in a clinical trial (ENDOBEST: ID-RCB 2024-A02092-45). Since the end of December 2025, it has been expanded and now covers a further 22,500 patients whose are not included in the trial. This medical device is based on Next-Generation Sequencing combined with analytical algorithms and enables the identification of endometriosis from a saliva sample. This non-invasive test aims to improve patient care by reducing diagnostic delays and guiding treatment strategies.
Despite the available data on its diagnostic performance, the impact of Endotest on patients' quality of life, their emotional experience, their coping strategies, and their care pathways remains insufficiently documented. Indeed, the Endotest result (positive or negative) can significantly influence these various aspects. This cohort study aims to assess the impact of Endotest on patients' quality of life, primarily using validated self-report questionnaires and clinical data from medical records. By including a large sample of patients, this study aims to provide robust and generalisable data that will be useful for clinicians and patients themselves.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a prescription for Endotest
- •Women aged 18 to 43
- •Who have dated and signed the consent form
- •Affiliated with the French healthcare system or covered by health insurance abroad
排除标准
- •Contraindications for the use of Endotest:
- •Current pregnancy;
- •Medical history of cancer or HIV infection;
- •Active infection at the time of saliva collection;
- •Significant difficulty reading and understanding the language of the country in which the participant is located.
研究组 & 干预措施
Endometriosis cohort performing Ziwig ENDOTEST®
干预措施: Questionnaire (Other)
结局指标
主要结局
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
时间窗: Day 1, 6 months and 12 months.
Endometriosis-specific quality of life score on the EHP-5 + 6 questionnaire (Endometriosis Health Profile - 11 items). Score goes from 0 to 44. Higher the score is, worse the outcome is.
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
时间窗: Day 1, 6 months and 12 months
Score for each of the 8 dimensions of quality of life on the RAND-36 questionnaire (declined version of the 36-Item Short Form Survey (SF-36)) Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is.
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
时间窗: 6 months
Factors associated with the level of endometriosis-specific quality of life (EHP-5+6 (Endometriosis Health Profile - 11 items)) at 6 months. Score goes from 0 to 44. Higher the score is, worse the outcome is.
次要结局
- Describe the impact of Endotest on adaptation strategies.(6 months)
- Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).(Through study completion, an average of 1 year)
- Describe the impact of Endotest's results immediately following the announcement.(1 month)
- Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).(Through study completion, an average of 1 year)
- To assess the impact of Endotest on anxiety levels.(1 month)
- Compare the care provided to patients with a positive Endotest result across participating countries.(Through study completion, an average of 1 year)
- Compare pelvic sensitivity based on Endotest results(Day 1 and 12 months)