Clinical trial · Interventional
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small-intestine Neuroendocrine Tumors (Carcinoid Tumors) | Neuroendocrine Tumor | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sample withdrawn | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patients with small-intestine neuroendocrine tumors
- interventionNames
- Biological: blood sample withdrawn
- type
- EXPERIMENTAL
- label
- control subjects with irritable bowel syndrome
- interventionNames
- Biological: blood sample withdrawn
Primary outcomes (1)
- measure
- urine 5HIAA value
- timeFrame
- 24-hour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTde Mestier L, Savagner F, Brixi H, Do Cao C, Dominguez-Tinajero S, Roquin G, Goichot B, Hentic O, Dubreuil O, Hautefeuille V, Walter T, Cadiot G. Plasmatic and Urinary 5-Hydroxyindolacetic Acid Measurements in Patients With Midgut Neuroendocrine Tumors: A GTE Study. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1673-e1682. doi: 10.1210/clinem/dgaa924. PMID 33382891