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Analytical Evaluation of the Endotest® Diagnostic (ENDORepro)

Primary Purpose

Endometriosis, Diagnosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Salivary Sampling
Sponsored by
ZIWIG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endometriosis focused on measuring Endometriosis, Diagnosis, Saliva sample, Repeatibility, Circadian cycle, Interferences, Stability

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Clinique Tivoli
  • CHU de Rouen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Research Planning

Arm 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.

Outcomes

Primary Outcome Measures

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)
Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
o evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)

Secondary Outcome Measures

Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the stability of the samples once they are collected
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the stability of the samples once they are collected
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
To evaluate the absence of interference on the analytical method and the signature
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
To evaluate the absence of interference on the analytical method and the signature

Full Information

First Posted
October 2, 2023
Last Updated
October 2, 2023
Sponsor
ZIWIG
Collaborators
Monitoring Force Group
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1. Study Identification

Unique Protocol Identification Number
NCT06072820
Brief Title
Analytical Evaluation of the Endotest® Diagnostic
Acronym
ENDORepro
Official Title
Analytical Evaluation of the Endotest® Diagnostic
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZIWIG
Collaborators
Monitoring Force Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Diagnosis
Keywords
Endometriosis, Diagnosis, Saliva sample, Repeatibility, Circadian cycle, Interferences, Stability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Research Planning
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Salivary Sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Description
To evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
Description
o evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
Time Frame
Through the end of repeatibility study, an average of 3 months
Secondary Outcome Measure Information:
Title
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Description
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Description
To evaluate the absence of variation during the day of the results of the Endotest® Diagnostic
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Description
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Description
To evaluate the intermediate fidelity of the Endotest® Diagnostic (analytical method and signature)
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Description
To evaluate the stability of the samples once they are collected
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Description
To evaluate the stability of the samples once they are collected
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
Description
To evaluate the absence of interference on the analytical method and the signature
Time Frame
Through the end of repeatibility study, an average of 3 months
Title
Change from baseline in the result (positive/negative) of the Endotest® Diagnostic
Description
To evaluate the absence of interference on the analytical method and the signature
Time Frame
Through the end of repeatibility study, an average of 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baptiste JUILLARD
Phone
+33 1 39 62 15 28
Email
baptiste.juillard@monitoring-force.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cassie RIBEIRO
Phone
+33 1 39 62 15 28
Email
cassie.ribeiro@monitoring-force.fr
Facility Information:
Facility Name
Clinique Tivoli
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin MERLOT, Dr
Phone
+33 5 56 11 60 92
First Name & Middle Initial & Last Name & Degree
Horace ROMAN, Pr
Phone
+33 5 56 11 60 92
First Name & Middle Initial & Last Name & Degree
Benjamin MERLOT, Dr
First Name & Middle Initial & Last Name & Degree
Horace ROMAN, Pr
Facility Name
CHU de Rouen
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde Hennetier, Dr
Phone
+33 2 32 88 89 90
First Name & Middle Initial & Last Name & Degree
Clotilde Hennetier, Dr
First Name & Middle Initial & Last Name & Degree
Hélène Breard, Dr
First Name & Middle Initial & Last Name & Degree
Patrice Crochet, Dr
First Name & Middle Initial & Last Name & Degree
Sophia Braund, Dr
First Name & Middle Initial & Last Name & Degree
Morgane Perrin, Dr
First Name & Middle Initial & Last Name & Degree
Audrey Real-Lhommet, Dr
First Name & Middle Initial & Last Name & Degree
Salma Touleimat, Dr

12. IPD Sharing Statement

Learn more about this trial

Analytical Evaluation of the Endotest® Diagnostic

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