Neuroendocrine TumorNCT00789841
Gastrointestinal Motility in Patients With Neuroendocrine Tumors
An observational study of Neuroendocrine Tumor, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Tumor
- What is being tested?
- Magnetic Tracking System (MTS) and radio-opaque markers
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Analfysiologisk afsnit, Aarhus University Hospital, Tage Hansensgade, entrance 11A
Aarhus, Aarhus, 8000
About this study
Official title: Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR
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.
- Conditions
- Neuroendocrine Tumor
- Being tested
- Magnetic Tracking System (MTS) and radio-opaque markers
- Keywords
- Neuroendocrine tumor, Carcinoid syndrome, Motility, Transit time
- Medical subject headings
- Neuroendocrine Tumors, Serotonin Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Tracking System (MTS) and radio-opaque markersDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with NET and diarrhea. | Not described Receives: Device: Magnetic Tracking System (MTS) and radio-opaque markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit time in NET patients
Measured: End of the study
Secondary outcomes (4)
Gastric emptying in NET patients
Measured: End of the study
Small intestinal transit time
Measured: End of the study
Small intestinal velocity
Measured: End of the study
Changes in carcinoid symptoms and biomarkers
Measured: End of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, The Danish Medical Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789841
- Sponsor's protocol ID
- M-20080121
- Status last verified
- Oct 2010
- First submitted
- 11 Nov 2008
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Motility in Patients With Neuroendocrine Tumors-Effects of Sandostatin LAR
- ClinicalTrials.gov ID
- NCT00789841
- Acronym / sponsor ID
- M-20080121
- Conditions
- Neuroendocrine Tumor
- Keywords
- Neuroendocrine tumor, Carcinoid syndrome, Motility, Transit time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Novartis, The Danish Medical Research Council
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with NET and diarrhea. | – | Device: Magnetic Tracking System (MTS) and radio-opaque markers |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Tracking System (MTS) and radio-opaque markersMTS: 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. | Device | Patients with NET and diarrhea. |
Primary outcome
Gastrointestinal transit time in NET patients
Time frame: End of the study
4 secondary outcomes
Gastric emptying in NET patients
Time frame: End of the study
Small intestinal transit time
Time frame: End of the study
Small intestinal velocity
Time frame: End of the study
Changes in carcinoid symptoms and biomarkers
Time frame: End of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumor, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal transit time in NET patients (time frame: End of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2010.