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

NCT02826928 | Completed

• 1 other identifier: PO15138*
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)

Outcome Measures

Primary Outcomes (1)

• urine 5HIAA value

  24-hour

Study Arms (2)

patients with small-intestine neuroendocrine tumors

EXPERIMENTAL

Biological: blood sample withdrawn

control subjects with irritable bowel syndrome

EXPERIMENTAL

Biological: blood sample withdrawn

Interventions

blood sample withdrawn BIOLOGICAL

control subjects with irritable bowel syndrome; patients with small-intestine neuroendocrine tumors

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

• de 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 RESULT

MeSH Terms

Conditions

Carcinoid Tumor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: October 26, 2016
• Primary Completion: February 28, 2020
• Study Completion: June 3, 2022
• Last Updated: January 21, 2026

Record last verified: 2022-06

Locations

FR (1)