NCT06072820尚未招募不适用
Analytical Evaluation of the Endotest® Diagnostic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- ZIWIG
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change from baseline in the result (Yes/No) of the Endotest® Diagnostic
时间窗: Through the end of repeatibility study, an average of 3 months
o evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable
时间窗: Through the end of repeatibility study, an average of 3 months
To evaluate the repeatability of Endotest® Diagnostic (analytical method and signature)
次要结局
- Analytical assessment of the Endotest® Diagnostic and result of the Endotest® Diagnostic: positive, negative, inconclusive, not assessable(Through the end of repeatibility study, an average of 3 months)
- Change from baseline in the result (positive/negative) of the Endotest® Diagnostic(Through the end of repeatibility study, an average of 3 months)
研究者
研究点 (4)
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