2023-506001-19-00招募中2 期
SDH-FLUX - Development of a new biomarker for tumor development in patients with SDHx mutation by in vivo fluxomics
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Presence or absence of a specific 13C6-glucose metabolism profile in patients' plasma
研究概览
简要总结
To determine the performance (sensitivity and specificity) of a 13C6-glucose test as a marker for the presence of a constitutional mutation in one of the SDHx genes in a patient with PPGL, compared to genetic testing (reference standard).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women over the age of 18
- •Diagnosis of PPGL established based on imaging or metanephrine measurements with a surgical indication
- •Signing the consent form
- •Enrolment in a social security system
排除标准
- •Uncontrolled diabetes HbA1c >8%
- •Insulin-treated diabetes
- •Estimated glomerular filtration rate < 30 mL/min/1.73 m² (MDRD formula)
- •Contraindication to glucose administration
- •Pregnancy, breastfeeding
- •Patient under guardianship, conservatorship, or judicial protection
- •Participation in another ongoing clinical trial or one for which the exclusion period has not ended, with the exception of the PREPA PHEO and COMETE CARE studies, which do not interfere with SDH-FLUX research
结局指标
主要结局
Presence or absence of a specific 13C6-glucose metabolism profile in patients' plasma
Presence or absence of a specific 13C6-glucose metabolism profile in patients' plasma
次要结局
- Capillary blood glucose measurement at different sampling times during the study.
- To identify the optimal time for sampling after administration of 13C6-glucose and the optimal infusion duration.
- The measured 13C-biomarker level will be compared to the tumor mass determined by preoperative imaging and to the tumor weight during histological analysis.
- Analysis of the metabolic profile of resected tumors
研究者
Laurence AMAR
Scientific
Assistance Publique Hopitaux De Paris
研究点 (2)
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