TumorNCT01084460
Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors
An observational study of Tumor, run by National Taiwan University Hospital.
Trial summary
Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tumor
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1997to Dec 2008
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective study. We reviewed 256 consecutive patients with the diagnosis of suspected gastric GISTs by EUS, from January 1997 to December 2008 at the National Taiwan University Hospital, Yuan's General Hospital and En Chu Kong Hospital.
Who may be able to join
- (1) a small tumor size, less than 3 cm;
- (2) patients declined surgical intervention at initial identification of the lesion;
- (3) at least two EUS follow-up procedures were recorded;
- (4) the EUS follow-up period was more than 24 months.
Who cannot join
- (1) a tumor size, larger than 3 cm;
- (2) less two EUS follow-up procedures were recorded;
- (3) the EUS follow-up period was less 24 months.
About this study
Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent progression with increased malignant potential.
- Conditions
- Tumor
- Keywords
- Gastrointestinal stromal tumor,endoscopic ultrasound,submucosal tumor
- Medical subject headings
- Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EUS-suspected gastric GISTs | In this retrospective study, 50 patients with EUS-suspected gastric GISTs, less than 3 cm were enrolled and had EUS follow-up at least two times over a period of more than 24 months. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 1997
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational model
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hsiu Po Wang, MD, Principal investigator, Department of Internal Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084460
- Sponsor's protocol ID
- 200812083R
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors
- ClinicalTrials.gov ID
- NCT01084460
- Acronym / sponsor ID
- 200812083R
- Conditions
- Tumor
- Keywords
- Gastrointestinal stromal tumor,endoscopic ultrasound,submucosal tumor
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Mar 2010 (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.
Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent progression with increased malignant potential.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-suspected gastric GISTs | – | –In this retrospective study, 50 patients with EUS-suspected gastric GISTs, less than 3 cm were enrolled and had EUS follow-up at least two times over a period of more than 24 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective study. We reviewed 256 consecutive patients with the diagnosis of suspected gastric GISTs by EUS, from January 1997 to December 2008 at the National Taiwan University Hospital, Yuan's General Hospital and En Chu Kong Hospital.
Key inclusion criteria (4 listed)
- (1) a small tumor size, less than 3 cm;
- (2) patients declined surgical intervention at initial identification of the lesion;
- (3) at least two EUS follow-up procedures were recorded;
- (4) the EUS follow-up period was more than 24 months.
Key exclusion criteria (3 listed)
- (1) a tumor size, larger than 3 cm;
- (2) less two EUS follow-up procedures were recorded;
- (3) the EUS follow-up period was less 24 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Mar 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.
Hsiu Po Wang, MD principal investigator
Department of Internal Medicine, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor, run by National Taiwan University Hospital.
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 3 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 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
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 10 Mar 2010.