Clinical trial NCT06072820: Analytical Evaluation of the Endotest® Diagnostic
Official title: Analytical Evaluation of the Endotest® Diagnostic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Diagnosis
Keywords: Endometriosis
Diagnosis
Saliva sample
Repeatibility
Circadian cycle
Interferences
Stability
Lead sponsor: ZIWIG
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
First posted: 2023-10-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
timeFrame: Through the end of repeatibility study, an average of 3 months
Secondary outcomes:
measure: Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
timeFrame: Through the end of repeatibility study, an average of 3 months
measure: Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
timeFrame: Through the end of repeatibility study, an average of 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli
state: Gironde
city: Rouen
country: France
facility: CHU de Rouen
state: Seine-Maritime
Study officials:
References: