Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
Primary Purpose
Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample withdrawn
Sponsored by
About this trial
This is an interventional diagnostic trial for Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)
Eligibility 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
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patients with small-intestine neuroendocrine tumors
control subjects with irritable bowel syndrome
Arm Description
Outcomes
Primary Outcome Measures
urine 5HIAA value
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02826928
Brief Title
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
Official Title
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
June 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-intestine Neuroendocrine Tumors (Carcinoid Tumors)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with small-intestine neuroendocrine tumors
Arm Type
Experimental
Arm Title
control subjects with irritable bowel syndrome
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood sample withdrawn
Primary Outcome Measure Information:
Title
urine 5HIAA value
Time Frame
24-hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33382891
Citation
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.
Results Reference
derived
Learn more about this trial
Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors
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