Gastrointestinal Motility in Patients With Neuroendocrine... | NCT00789841

Studies
Gastrointestinal Motility in Patients With Neuroendocrine Tumors

NCT00789841

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 26, 2010Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Neuroendocrine Tumor

Interventions

Magnetic Tracking System (MTS) and radio-opaque markers

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Nov 11, 2008

First Submission Date that Met QC Criteria

Nov 12, 2008

First Posted Date

Nov 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2010

Last Update Posted Date

Oct 26, 2010Estimated

Name	Class
Novartis	INDUSTRY
The Danish Medical Research Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We will study the total gastrointestinal transit time (GITT), gastric emptying and small intestine motility in NET patients before and after treated with somatostatin analogues and compare these to healthy subjects. For this we will use radio-opaque markers and the newly developed Motility Tracking System (MTS).

Hypothesis: Patients with NET and carcinoid syndrome have decreased GITT, gastric emptying and small bowel transit time and an increase in phase III MMC activity compared to healthy subjects. Treatment with somatostatin analogues increase transit times and decrease phase III MMC activity and improves the clinical symptoms.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with NET and diarrhea.			Device: Magnetic Tracking System (MTS) and radio-opaque markers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Tracking System (MTS) and radio-opaque markers	Device	MTS: A small magnetic pill (6x15mm) is swallowed by the patient and the movement of this pill is registered by a sensor (coordinates x,y,z angles θ, φ) and depicted af graphs on a computer screen. For determination of GITT a capsule containing 10 radio-opaque markers is ingested every day for six days, on day seven an abdominal x-ray is performed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastrointestinal transit time in NET patients		End of the study

Secondary Outcomes

Measure	Description	Time Frame
Gastric emptying in NET patients		End of the study
Small intestinal transit time		End of the study
Small intestinal velocity

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A		Aarhus	Aarhus	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors
D020230	Serotonin Syndrome

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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