Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-10-31
2024-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Research Planning
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.
Salivary Sampling
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.
Interventions
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Salivary Sampling
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.
Eligibility Criteria
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Inclusion Criteria
* 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,
* Subject participating in an interventional study or in the exclusion period of an interventional study.
Exclusion Criteria
* 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.
18 Years
43 Years
FEMALE
No
Sponsors
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Monitoring Force Group
INDUSTRY
ZIWIG
INDUSTRY
Responsible Party
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Locations
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Clinique Tivoli
Bordeaux, Gironde, France
CHU de Rouen
Rouen, Seine-Maritime, France
Countries
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Central Contacts
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Facility Contacts
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Benjamin MERLOT, Dr
Role: primary
Horace ROMAN, Pr
Role: backup
Clotilde Hennetier, Dr
Role: primary
Other Identifiers
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2023-03
Identifier Type: -
Identifier Source: org_study_id
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