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

Condition(s) studied

Investigational drug(s) / intervention(s)

Questionnaire: EHP 5+6, RAND-36 et 6 and 12 months follow-up visits

Study summary

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.

Eligibility

Primary outcome measure(s)

• To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. — 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. — 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. — 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.
• To assess the impact of Endotest on quality of life and identify the factors associated with quality of life. — 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.

Trial sites (7)

More ZIWIG trials in France