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临床试验/NCT02815969
NCT02815969已完成不适用

Exploring the Metabolic Profile of Neuroendocrine Tumors

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
1
主要终点
indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma

研究概览

简要总结

This is an observational and exploratory study. Participants will be asked for a blood collection and a 24- hour collection of urine. The indol profile and levels of catecholamine and metabolites in PRP, as well as in 24- hour collection of urine will be measured with LC-MS/MS and analyzed.

详细描述

Rationale:

Neuro-endocrine neoplasms are a diverse group of tumors which encompasses heterogeneous clinical courses. Different NETs are characterized by differences in the synthesis, storage and release of biogenic amines and their metabolites, e.g. indoles, catecholamines and their metabolites. Clinical course, prognosis, and treatment are based, among others, on the origin of the primary tumor. Up to now it was only possible to measure metabolic output of NETs by serotonin in platelets and 5-HIAA in urine. Due to technical improvements we can now measure the complete metabolic pathway of serotonin in plasma and urine, which comprises tryptophan, 5-hydroxytryptophan, serotonin and 5-HIAA, the indol profile. Furthermore, levels of catecholamines and metabolites can now be analyzed in the same sample. This metabolic profiling could potentially lead to improved diagnosis and characterization of NET patients and possibly contribute to subsequent treatment consequences.

Therefore, we want to perform an exploratory study to measure the indol profile, catecholamines and metabolites in patients with NETs of different origin (foregut, midgut and hindgut) and assess differentiation of their metabolic profile.

Objective:

The aim of this study is to explore the added value of the indol profile in comparison to serotonin in platelets and 5-HIAA in urine for diagnosis and potentially management of neuroendocrine tumors including gastrinomas, pNETs and brochopulmonary NETs.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma

时间窗: at one visit

indol profile in platelet rich plasma

次要结局

  • catecholamines; L-DOPA, Dopamine, Norepinephrine, Epinephrine, -Methoxytyramine, Normetanephrine, Metanephrine in platelet rich plasma(at one visit)
  • indoles and catecholamines; L-DOPA, 5-HTP, Dopamine, Norepinephrine, Epinephrine, 3-Methoxytyramine, Normetanephrine, Metanephrine, Serotonin, 5-Hydroxyindolacetic acid(at one visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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