Gastrointestinal Stromal Cell TumorsNCT02147145
Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)
An observational study of Gastrointestinal Stromal Cell Tumors and Foregut Subepithelial Lesions, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis: Patient compliance with a GIST surveillance program will be low. Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change significantly during a surveillance program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Cell Tumors, Foregut Subepithelial Lesions
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2014
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (>18 years of age) referred for EUS evaluation of incidentally discovered foregut SEL at a two tertiary care centers between 8/2008 and 8/2012.
Who may be able to join
- presenting for EUS with an indication for a SEL in the stomach or esophagus
- at least 18 years of age
- able to provide informed consent
Who cannot join
- no subepithelial lesion in the stomach or esophagus'
- less than 18 years of age
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis: Patient compliance with a GIST surveillance program will be low.
Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change significantly during a surveillance program.
Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly during a surveillance program.
Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of GIST size.
Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.
- Keywords
- GIST, endoscopy, endoscopic ultrasound
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 |
|---|---|---|
| Observation Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.
Measured: 3 years
Secondary outcomes (3)
Determine the degree of patient compliance with surveillance recommendations.
Measured: 3 years
Describe the diagnostic yield of EUS±FNA in evaluating SELs.
Measured: 2 weeks
Compare SEL size estimation based on EUS, EGD and computer tomography (CT).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startAug 2008
- Primary completionAug 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal Cell TumorsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prospective
- Enrolment
- 187 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147145
- Sponsor's protocol ID
- ProGIST 1
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 26 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)
- ClinicalTrials.gov ID
- NCT02147145
- Acronym / sponsor ID
- ProGIST 1
- Keywords
- GIST, endoscopy, endoscopic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 May 2014 (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.
Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis: Patient compliance with a GIST surveillance program will be low.
Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change significantly during a surveillance program.
Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly during a surveillance program.
Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of GIST size.
Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (>18 years of age) referred for EUS evaluation of incidentally discovered foregut SEL at a two tertiary care centers between 8/2008 and 8/2012.
Key inclusion criteria (3 listed)
- presenting for EUS with an indication for a SEL in the stomach or esophagus
- at least 18 years of age
- able to provide informed consent
Key exclusion criteria (3 listed)
- no subepithelial lesion in the stomach or esophagus'
- less than 18 years of age
- unable to provide informed consent
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
Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.
Time frame: 3 years
3 secondary outcomes
Determine the degree of patient compliance with surveillance recommendations.
Time frame: 3 years
Describe the diagnostic yield of EUS±FNA in evaluating SELs.
Time frame: 2 weeks
Compare SEL size estimation based on EUS, EGD and computer tomography (CT).
Time frame: 1 day
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 May 2014.
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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 Gastrointestinal Stromal Cell Tumors and Foregut Subepithelial Lesions, run by Washington University School of Medicine at 1 site in United States.
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 3 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 26 May 2014. 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 United States. 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?
Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS. (time frame: 3 years). 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 May 2014.