Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors

Not Applicable

Completed

• Conditions: Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)
• Interventions: Biological: blood sample withdrawn

• Registration Number: NCT02826928
• Lead Sponsor: CHU de Reims

Brief Summary

Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker has good specificity, its sensitivity is moderate and its dosage is constraining, since it requires urine collection over 2-3 days and specific diet. Preliminary data suggested that overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.

Detailed Description

This study primarily aims at comparing the sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors. Secondary objectives include the correlation of 5HIAA values with chromogranin A, carcinoid syndrome and tumor burden and the evaluation of the compliance to the diet and its correlation with 5HIAA values.

The study group will include patients with proven neuroendocrine tumors of various stages and functioning syndrome profile. A control group will be constituted with subjects having irritable bowel syndrome, in which a neuroendocrine tumor is ruled out. After providing informed consent, patients fitting with inclusion criteria will be included in the study. Patients will have to follow a specific diet, and interrupt/avoid certain medication, during the 2 days before and the 2 days during the sampling period. Whole urine samples will be collected during 2 consecutive days, in 4 parts (day1, night 1, day 2, night 2). Blood samples will be collected at the morning of days 2 and 3. Observance with diet and drug restriction will be evaluated at the morning of day 3.

Study Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Study Start: 2016-10-26
• Primary Completion: 2020-02-28
• Status Verified: 2022-06
• Study Completion: 2022-06-03
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with small-intestine neuroendocrine tumors	blood sample withdrawn	-
control subjects with irritable bowel syndrome	blood sample withdrawn	-

Primary Outcome Measures

Name	Time	Method
urine 5HIAA value	24-hour

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France