NCT06072820

Brief Summary

This is an interventional with minimal risks and constraints (RIPH 2 in France), prospective, longitudinal, non-randomized, multicenter study. The present study will allow us to evaluate multiple factors assessing the Endotest® Diagnostic accuracy and its possible limitations. To characterize the Endotest® Diagnostic, the following parameters will be evaluated:

  • Repeatability: the verification of the invariability of its results without condition changes,
  • Circadian cycle: whether the circadian cycle affects the determination of the signature,
  • Intermediate fidelity: the verification of the invariability of its results with an operator change,
  • Interferences: the impact of different interferences on its results,
  • Stability: the possible modification of its results depending on the samples conditions of storage. The acts and procedures performed in this research will be divided into three visits:
  • Inclusion visit: performance of 4 Endotest® Diagnostics (3 at the visit and 1 at home) by the 60 included subjects,
  • "Circadian cycle" visit: performance of 17 Endotest® Diagnostics (14 at the visit and 3 post-visit at home) by 6 subjects selected after evaluation of the results of the inclusion visit,
  • "Repeatability-intermediate fidelity-interference-stability" visit: realization of 17 Endotest® Diagnostic by 10 or 16 subjects, depending on the results of the impact of the circadian cycle on the saliva signature. These subjects will be selected according to the results of the inclusion visit, excluding those who participated in the circadian cycle visit.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

October 2, 2023

Last Update Submit

March 23, 2026

Conditions

EndometriosisDiagnosis

Keywords

EndometriosisDiagnosisSaliva sampleRepeatibilityCircadian cycleInterferencesStability

Outcome Measures

Primary Outcomes (2)

  • Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable

    To evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)

    Through the end of repeatibility study, an average of 3 months

  • Change from baseline in the result (Yes/No) of the Endotest® Diagnostic

    o evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)

    Through the end of repeatibility study, an average of 3 months

Secondary Outcomes (8)

  • Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable

    Through the end of repeatibility study, an average of 3 months

  • Change from baseline in the result (positive/negative) of the Endotest® Diagnostic

    Through the end of repeatibility study, an average of 3 months

  • Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable

    Through the end of repeatibility study, an average of 3 months

  • Change from baseline in the result (positive/negative) of the Endotest® Diagnostic

    Through the end of repeatibility study, an average of 3 months

  • Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable

    Through the end of repeatibility study, an average of 3 months

  • +3 more secondary outcomes

Study Arms (1)

Research Planning

OTHER

Study population will be composed of subject with a confirmed or ruled-out diagnosis of endometriosis. The subject diagnosis could be ascertained through imaging and/or surgery with or without biopsies. After a first assessment during a routing care visit, the subject will be asked to come back for a day, or half a day depending on the impact of the circadian cycle.

Device: Salivary Sampling

Interventions

Salivary SamplingDEVICE

Inclusion visit: After signature of the informed consent, all subjects will perform 3 consecutive Endotest® Diagnostic during the visit and 1 at-home. Circadian circle visit: 6 included subjects will be asked to come back for a full day. They will have to perform 17 Endotest® Diagnostic: 14 on study site and 3 at home after the visit. Repeatability-intermediate fidelity-stability-interferences visit: a maximum of 16 included subjects will be asked to come back for this visit. They will have to perform 17 Endotest® Diagnostic: 14 on study site and 3 at home after the visit.

Research Planning

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject aged 18 years to 43 years,
  • Subject having dated and signed the consent form,
  • Subject affiliated to the French health system,
  • Subject able to return for a full day for the rest of the study,
  • Subject whose diagnosis of endometriosis has been established with certainty or definitively ruled out.
  • Pregnant subject,
  • Subject with an acute or chronic infection (viral hepatitis, HIV...),
  • Subject with history of hypersensitivity or allergy,
  • Subject with a personal history of cancer,
  • Subjects with significant difficulties in reading or writing the French language,
  • Subject unable to comply with the study and/or follow-up procedures,
  • Subject who has objected to the collection of her data,

You may not qualify if:

  • Pregnant subject,
  • Subject with acute or chronic infection (viral hepatitis, HIV...),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique Tivoli

Bordeaux, Gironde, 33000, France

Location

CHU de Rouen

Rouen, Seine-Maritime, 76000, France

Location

MeSH Terms

Conditions

EndometriosisDisease

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 10, 2023

Study Start

October 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

FR(2)