Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02826928 |
| Other study ID # |
PO15138* |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 26, 2016 |
| Est. completion date |
June 3, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
