Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-25 @ 4:17 AM
Ignite Modification Date: 2025-12-25 @ 4:17 AM
NCT ID: NCT06072820
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.
Study: NCT06072820
Study Brief:
Protocol Section: NCT06072820