Gastrointestinal Stromal TumorsNCT00877045
Treatment Patterns in Gastrointestinal Stromal Tumors in the Community Oncology Setting
An observational study of Gastrointestinal Stromal Tumors, run by SCRI Development Innovations, LLC at 5 sites in United States.
Trial summary
This is a retrospective medical record abstraction to evaluate the patterns of care for Gastrointestinal stromal tumors (GIST) in the community setting. Patient demographics and characteristics along with the treatments received will be described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Feb 2009
- 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: Patients diagnosed with GIST based on ICD-9 code from January 2005 to present will be eligible. This will include current active patients as well as patients who have expired and have medical chart available. Estimate reviewing approximately 300 charts total.
Who may be able to join
- Patients diagnosed with GIST based on ICD-9 code from January 2005 to present will be eligible. This will include current active patients as well as patients who have expired and have medical chart available.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Georgia Cancer Specialists
Atlanta, Georgia, 30341
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Florida Cancer Specialists
Fort Myers, Florida, 33901
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Virginia Cancer Institute
Richmond, Virginia, 23235
About this study
This is a retrospective medical record abstraction to evaluate the patterns of care for Gastrointestinal stromal tumors (GIST) in the community setting. Patient demographics and characteristics along with the treatments received will be described. Investigators will establish the percentage of patients who undergo surgery, the percentage of patients who are treated with kinase inhibitors as well as in what setting (adjuvant or metastatic) as well as the duration of therapy. Physician information will also be collected to assess for differences in treatment based on physician or geographical differences.
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, GIST, tyrosine kinase inhibitors, Imatinib, Gleevec, Suntinib, Sutent
- Medical subject headings
- Gastrointestinal Stromal Tumors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Jeffrey F Patton, M.D., Study chair, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877045
- Sponsor's protocol ID
- SCRI OUTCOMES 01
- Status last verified
- Aug 2010
- First submitted
- 3 Apr 2009
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns in Gastrointestinal Stromal Tumors in the Community Oncology Setting
- ClinicalTrials.gov ID
- NCT00877045
- Acronym / sponsor ID
- SCRI OUTCOMES 01
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, GIST, tyrosine kinase inhibitors, Imatinib, Gleevec, Suntinib, Sutent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Apr 2009 (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.
This is a retrospective medical record abstraction to evaluate the patterns of care for Gastrointestinal stromal tumors (GIST) in the community setting. Patient demographics and characteristics along with the treatments received will be described. Investigators will establish the percentage of patients who undergo surgery, the percentage of patients who are treated with kinase inhibitors as well as in what setting (adjuvant or metastatic) as well as the duration of therapy. Physician information will also be collected to assess for differences in treatment based on physician or geographical differences.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with GIST based on ICD-9 code from January 2005 to present will be eligible. This will include current active patients as well as patients who have expired and have medical chart available. Estimate reviewing approximately 300 charts total.
Key inclusion criteria (1 listed)
- Patients diagnosed with GIST based on ICD-9 code from January 2005 to present will be eligible. This will include current active patients as well as patients who have expired and have medical chart available.
Key exclusion criteria (0 listed)
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 4 Aug 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.
Jeffrey F Patton, M.D. study chair
SCRI Development Innovations, LLC
5 sites 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 Tumors, run by SCRI Development Innovations, LLC at 5 sites 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 1 inclusion and 0 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 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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 4 Aug 2010.