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

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ClinicalTrials.gov Identifier: NCT02826928
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Small-intestine Neuroendocrine Tumors (Carcinoid Tumors) Biological: blood sample withdrawn Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
Actual Study Start Date : October 26, 2016
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : January 2020


Arm Intervention/treatment
Experimental: patients with small-intestine neuroendocrine tumors Biological: blood sample withdrawn
Experimental: control subjects with irritable bowel syndrome Biological: blood sample withdrawn



Primary Outcome Measures :
  1. urine 5HIAA value [ Time Frame: 24-hour ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826928


Contacts
Contact: Guillaume Cadiot 326788441 gcadiot@chu-reims.fr

Locations
France
Chu Reims Recruiting
Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02826928     History of Changes
Other Study ID Numbers: PO15138
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial