Endometriosis (Diagnosis), Patient With a Prescribed Endotest
Conditions
Keywords
endometriosis
Brief 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.
Interventions
OTHERQuestionnaire
EHP 5+6, RAND-36 et 6 and 12 months follow-up visits
Sponsors
ZIWIG
Monitoring Force Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the impact of Endotest on adaptation strategies. | 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 |
| 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 | Number of patients starting an assisted reproductive technology (ART) treatment programme |
| Describe the impact of Endotest's results immediately following the announcement. | 1 month | Personalised questionnaire on immediate emotional reactions |
| Describe the impact of Endotest on patient care: tests, treatments, and additional procedures (e.g., laparoscopy). | Through study completion, an average of 1 year | Number and type of additional tests or procedures performed (ultrasound, MRI, laparoscopy, etc.). |
| To assess the impact of Endotest on anxiety levels. | 1 month | Visual Analog Scale Anxiety Score Score goes from 0 to 100 Lower the score is, better the outcome is |
| Compare the care provided to patients with a positive Endotest result across participating countries. | Through study completion, an average of 1 year | Type of coverage and waiting period |
| Compare pelvic sensitivity based on Endotest results | 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. |
Countries
France
Contacts
CONTACTFabien Le Floc'h, Project Manager
Outcome results
None listed