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Impact of Endotest on Patients' Quality of Life: a Cohort Study (ENDOLIFE)

2026年5月20日 更新者：ZIWIG

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

20000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 法国
    • Gironde
      • Bordeaux、Gironde、法国、33000
        • 招聘中
        • Clinique Tivoli Ducos
        • 接触：
    • Ille-et-Vilaine
      • Saint-Grégoire、Ille-et-Vilaine、法国、35760
        • 尚未招聘
        • Hôpital privé Saint-Grégoire
        • 接触：
    • Morbihan
      • Lorient、Morbihan、法国、56100
        • 尚未招聘
        • Groupe Hospitalier Bretagne Sud - GHBS - Lorient
        • 接触：
    • Moselle
    • Pays de la Loire Region
      • Saint-Priest-en-Jarez、Pays de la Loire Region、法国、42270
    • Pyrénées Atlantiques
      • Pau、Pyrénées Atlantiques、法国、64000
        • 尚未招聘
        • Centre Hospitalier de Pau
        • 接触：
    • Seine-maritime
      • Montivilliers、Seine-maritime、法国、76290
        • 尚未招聘
        • Hôpital Jacques Monod - GH du Havre
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

概率样本

研究人群

Patient with endometriosis for whom an Endotest is prescribed

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindications for the use of Endotest:

    1. Current pregnancy;
    2. Medical history of cancer or HIV infection;
    3. Active infection at the time of saliva collection;
  • Significant difficulty reading and understanding the language of the country in which the participant is located.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Endometriosis cohort performing Ziwig ENDOTEST®
其他：Questionnaire
EHP 5+6, RAND-36 et 6 and 12 months follow-up visits

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
大体时间：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.
Day 1, 6 months and 12 months.
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
大体时间：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.
Day 1, 6 months and 12 months
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
大体时间：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.
6 months
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
大体时间：6 months

Factors associated with the level of each of the 8 dimensions of general quality of life (RAND-36 (declined version of the 36-Item Short Form Survey (SF-36)) at 6 months.

Score goes from 0 to 100 for each ones of the 8 dimensions. Higher the score is, better the outocome is.
6 months

次要结果测量

结果测量
措施说明
大体时间
Describe the impact of Endotest on adaptation strategies.
大体时间：6 months
Brief-COPE score (Brief Coping Orientation to Problems Experienced) Score goes from 1 to 4 for the 3 subscales (Problem Focussed, Emotion Focussed, Avoidant) There is no direct correlation between higher/lower scores and better/worse outcomes
6 months
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
大体时间：Through study completion, an average of 1 year
Number of patients starting an assisted reproductive technology (ART) treatment programme
Through study completion, an average of 1 year
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
大体时间：Through study completion, an average of 1 year
Number of patients for whom the ART treatment plan is amended (e.g. switching from intrauterine insemination to IVF, surgery)
Through study completion, an average of 1 year
Describe the impact of Endotest's results immediately following the announcement.
大体时间：1 month
Personalised questionnaire on immediate emotional reactions
1 month
Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
大体时间：Through study completion, an average of 1 year
Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.).
Through study completion, an average of 1 year
Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy).
大体时间：Through study completion, an average of 1 year
Initiation or modification of treatments (hormonal, pain relievers, etc.).
Through study completion, an average of 1 year
To assess the impact of Endotest on anxiety levels.
大体时间：1 month
Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is
1 month
Compare the care provided to patients with a positive Endotest result across participating countries.
大体时间：Through study completion, an average of 1 year
Type of coverage and waiting period
Through study completion, an average of 1 year
Compare pelvic sensitivity based on Endotest results
大体时间：Day 1 and 12 months
Convergences Score for Pelvic-Perineal Pain Score goes from 0 to 10 Lower the score is, better the outcome is.
Day 1 and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ZIWIG

合作者

Monitoring Force Group

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月6日

初级完成 (估计的)

2029年7月31日

研究完成 (估计的)

2029年7月31日

研究注册日期

首次提交

2026年4月8日

首先提交符合 QC 标准的

2026年4月23日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月26日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025ZW03
  • 2026-A00166-45 (其他标识符：ANSM)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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