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临床试验/NCT06044662
NCT06044662招募中不适用

The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Disease Severity

研究概览

简要总结

Biomarkers for prognosis of patients with polyneuropathy.

详细描述

AIM: To investigate biomarkers' use as a prognostic tool in polyneuropathy patients.

STUDY DESIGN: Prospective cohort study of patients with polyneuropathy. METHODS: 200 patients with polyneuropathy will be examined with physical tests, medical examination, questionnaires, and blood biomarkers at baseline and at 1-year follow-up, and 2-year follow-up.

ANALYSIS: The investigators will calculate the odds of disease progression after 2 years depending on biomarkers levels at baseline using multiple logistic regression with sex and age adjustment. Diagnostic performance of the physical tests and biomarkers for prediction of disease progression will be assessed by Receiver Operating Characteristic Curve analysis with the area under the curve.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum 18 years old.
  • Diagnosed with polyneuropathy, confirmed by nerve conduction study.
  • Can read and understand Danish.

排除标准

  • Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.

结局指标

主要结局

Disease Severity

时间窗: 2 years

Primary outcome is disease severity

次要结局

  • Patient Reported Outcomes (PROMs)(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Sloth Kodal

MD

Rigshospitalet, Denmark

研究点 (1)

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