Analytical Evaluation of the Endotest® Diagnostic (ENDORepro)

Ziwig

Status: Not yet enrolling

Conditions: Diagnosis; Endometriosis

Treatments: Device: Salivary Sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT06072820

2023-03

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Non-Inclusion criteria:

• 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,
• Subject participating in an interventional study or in the exclusion period of an interventional study.

Exclusion criteria

• Pregnant subject,
• Subject with acute or chronic infection (viral hepatitis, HIV...),
• Subject unable to comply with study and/or follow-up procedures (including absence of outside salivary sample after the inclusion visit),
• Subject participating in an interventional study or in the exclusion period of an interventional study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Research Planning

Other group

Description:

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.

Treatment:

Device: Salivary Sampling