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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 : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date  ICMJE July 5, 2016
First Posted Date  ICMJE July 11, 2016
Last Update Posted Date December 16, 2019
Actual Study Start Date  ICMJE October 26, 2016
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
urine 5HIAA value [ Time Frame: 24-hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
Official Title  ICMJE Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)
Intervention  ICMJE Biological: blood sample withdrawn
Study Arms  ICMJE
  • Experimental: patients with small-intestine neuroendocrine tumors
    Intervention: Biological: blood sample withdrawn
  • Experimental: control subjects with irritable bowel syndrome
    Intervention: Biological: blood sample withdrawn
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2016)
120
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guillaume Cadiot 326788441 gcadiot@chu-reims.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02826928
Other Study ID Numbers  ICMJE PO15138
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHU de Reims
Study Sponsor  ICMJE CHU de Reims
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHU de Reims
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP