Impact of Endotest on Patients' Quality of Life: a Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-43
SponsorZIWIG
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patient with endometriosis for whom an Endotest is prescribed
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaire
Other interventionEHP 5+6, RAND-36 et 6 and 12 months follow-up visits
Treatment groups
20,000 Participants
are divided into 1 treatment groupGroup A: Endometriosis cohort performing Ziwig ENDOTEST®1 intervention
Trial outcomes
Primary outcomes
1
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
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.
Time frame
Day 1, 6 months and 12 months.2
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
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.
Time frame
Day 1, 6 months and 12 months3
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
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.
Time frame
6 months4
To assess the impact of Endotest on quality of life and identify the factors associated with quality of life.
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.
Time frame
6 monthsSecondary outcomes
1
Describe the impact of Endotest on adaptation strategies.
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
Time frame
6 months2
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
Number of patients starting an assisted reproductive technology (ART) treatment programme
Time frame
Through study completion, an average of 1 year3
Describe the impact of Endotest on the assisted reproductive technology (ART) journey (including infertility assessment and fertility preservation).
Number of patients for whom the ART treatment plan is amended (e.g. switching from intrauterine insemination to IVF, surgery)
Time frame
Through study completion, an average of 1 year4
Describe the impact of Endotest's results immediately following the announcement.
Personalised questionnaire on immediate emotional reactions
Time frame
1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
ZIWIG
Lead sponsor
Monitoring Force Group
Collaborator
Source ClinicalTrials.gov