Small Bowel Function in NET Patients - a Clinical Perspective - Full Text View

Sponsors and Collaborators:	University of Aarhus Novartis The Danish Medical Research Council
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00789841

Purpose

We will study the small intestine movements in NET patients before and after treated with somatostatin analogues. For this we will use the newly developed Magnetic Tracking System (MTS).

Hypothesis: Patients with NET and carcinoid syndrome have increased small bowel motility, and treatment with somatostatin analogues reduces motility and improves the clinical symptoms.

Condition	Intervention
Neuroendocrine Tumor	Device: Magnetic Tracking System (MTS)

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Small Bowel Function in NET Patients - a Clinical Perspective

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Small bowel transit time in NET patients [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gastric emptying in NET patients [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Frequency of propulsive and non-propulsive intestinal contractions [ Time Frame: End og the study ] [ Designated as safety issue: No ]
Average distance covered by each propulsive intestinal contraction [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Colorectal transit time [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood samples wich are destroyed after analysis

Estimated Enrollment:	12
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

We are scheduling 12 subjects (30-80 years of age) with NET and carcinoid syndrome with diarrhea. Patients are recruited through the Department of Medicine V, Aarhus University Hospital.

Criteria

Inclusion Criteria:

NET confirmed by histology
Diarrhea, (at least 3 loose or watery bowel movements per day) as part of carcinoid syndrome.
Newly referred patients without previous somatostatin analogue treatment or
NET patients who are pausing somatostatin analogue treatment due to other treatment or examination.

Exclusion Criteria:

Subjects unable to understand the information
Severe diabetes with late complications or known metabolic disorder
Inflammatory bowel disease
Known clinically significant stenosis of the bowel
Bile acid malabsorption due to intestinal surgery
Small bowl bacterial overgrowth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789841

Contacts

Contact: Henning Grønbæk, Consulting hepatologist, PhD	+4589491546	hgron@as.aaa.dk
Contact: Tine Gregersen, medical student	+4522334161	tig@studmed.au.dk

Locations

Denmark
Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A	Recruiting
Aarhus, Denmark, 8000
Contact: Tine Gregersen, Medicla student +4522334161 tig@studmed.au.dk

Sponsors and Collaborators

University of Aarhus

Novartis

The Danish Medical Research Council

More Information

Responsible Party:	Medical Department V, Aarhus University Hospital ( Henning Grønbæk, M.D., Ph.D. )
Study ID Numbers:	M-20080121
Study First Received:	November 11, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00789841
Health Authority:	Denmark: National Board of Health

Keywords provided by University of Aarhus:

Neuroendocrine tumor
Carcinoid syndrome
Motility
Transit time

Study placed in the following topic categories:

Carcinoid tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Serotonin Syndrome
Neuroepithelioma

Carcinoid Tumor
Malignant Carcinoid Syndrome
Carcinoid syndrome
Neuroendocrine Tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009