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

NCT07560852 | Not Yet Recruiting

• 2 other identifiers: 2025ZW032026-A00166-45
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Patient With a Prescribed Endotest; Endometriosis (Diagnosis)

Keywords

endometriosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

Secondary Outcomes (9)

• 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 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

Study Arms (1)

Endometriosis cohort performing Ziwig ENDOTEST®

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Endometriosis cohort performing Ziwig ENDOTEST®

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient with endometriosis for whom an Endotest is prescribed

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZIWIG: lead
• Monitoring Force Group: collaborator

Study Sites (7)

Clinique Tivoli Ducos

Bordeaux, Gironde, 33000, France

Location

Hôpital privé Saint-Grégoire

Saint-Grégoire, Ille-et-Vilaine, 35760, France

Location

Groupe Hospitalier Bretagne Sud - GHBS - Lorient

Lorient, Morbihan, 56100, France

Location

Hôpital de Mercy - CHR Metz Thionville

Peltre, Moselle, 57245, France

Location

CHU de Saint Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

Centre Hospitalier de Pau

Pau, Pyrénées Atlantiques, 64000, France

Location

Hôpital Jacques Monod - GH du Havre

Montivilliers, Seine-maritime, 76290, France

Location

MeSH Terms

Conditions

Endometriosis; Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Fabien Le Floc'h, Project Manager

CONTACT

+330630447709; fabien.lefloch@monitoring-force.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 1, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (7)