Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients … (NCT02826928) | Clinical Trial Compass
CompletedNot Applicable
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
France116 participantsStarted 2016-10-26
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria:
* Histologically proven small-intestine neuroendocrine tumors, at initial diagnosis or during the follow-up
* Irritable bowel syndrome, diagnosed following Rome III criteria, who had an ileo-colonoscopy and an abdominal CT-scan within the 12 last months
* Age \> 18 years
* No antitumor treatment within the last three months excepted somatostatin analogs
* Ability of understanding and approving the study protocol and of providing written consent
* Affiliation to the French Health Social System
Exclusion criteria
* Small-intestine neuroendocrine tumor in remission (no detectable disease)
* Other malignancies than small-intestine neuroendocrine tumors (excepted if in remission for more than 2 years)
* Kidney insufficiency (MDRD \< 60/min)
* Urinary incontinency or inability to collect urines
* Any antitumor treatment within the last three months excepted somatostatin analogs
* Inability to interrupt treatments interfering with 5HIAA dosage
* Pregnancy
* Patients under law protection