Analytical Evaluation of the Endotest® Diagnostic

Endometriosis Clinical Trial

— ENDORepro  

Official title:

Analytical Evaluation of the Endotest® Diagnostic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06072820
• Other study ID #: 2023-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: ZIWIG
• Contact: Baptiste JUILLARD
• Phone: +33 1 39 62 15 28
• Email: baptiste.juillard[@]monitoring-force.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Endometriosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Clinique Tivoli	Bordeaux	Gironde
France	CHU de Rouen	Rouen	Seine-Maritime

Sponsors (2)

Lead Sponsor	Collaborator
ZIWIG	Monitoring Force Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Through the end of repeatibility study, an average of 3 months
Secondary	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	Through the end of repeatibility study, an average of 3 months
Secondary	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)	Through the end of repeatibility study, an average of 3 months
Secondary	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)	Through the end of repeatibility study, an average of 3 months
Secondary	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	Through the end of repeatibility study, an average of 3 months
Secondary	Change from baseline in the result (positive/negative) of the Endotest® Diagnostic	To evaluate the stability of the samples once they are collected	Through the end of repeatibility study, an average of 3 months
Secondary	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	Through the end of repeatibility study, an average of 3 months
Secondary	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	Through the end of repeatibility study, an average of 3 months