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Gastrointestinal Stromal Tumors (GIST) Registry

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507273
First received: July 25, 2007
Last updated: August 1, 2012
Last verified: August 2012

July 25, 2007
August 1, 2012
August 2005
December 2010   (final data collection date for primary outcome measure)
Current patterns of medical practice in management of patients with GIS [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Data from observational GIST Registry analyzed to describe current patterns.
Not Provided
Complete list of historical versions of study NCT00507273 on ClinicalTrials.gov Archive Site
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Gastrointestinal Stromal Tumors (GIST) Registry
Gastrointestinal Stromal Tumors (GIST) Registry Protocol: reGISTry

The goal of this observational research study is to establish a registry of information regarding how different physicians treat and manage patients with gastrointestinal stromal tumors (GISTs).

Objectives:

  1. To describe variation in management of patients with GIST, overall and by patient and provider characteristics.
  2. To provide participating physicians with information regarding management of their patients with GIST compared to the aggregate experience of all physicians participating in the Registry.

The Registry, which is Internet based, is intended to collect information about current practices in the management of GIST without making any specific change to the standard of care as decided by each patient's treating physician.

If you agree to participate in this study, your doctor will provide information to a data registry about your physical and clinical traits, the past and current medical care you have received to treat your GIST, and clinically-related, economically-related, and health-related quality of life information. About 200 doctors will provide information on their patients for the Registry. Your doctor will collect this information when you first join the Registry and at each regularly scheduled visit you make to your doctor's office. The information collection will continue for as long as you and your doctor feel it is appropriate. The information that is entered into the Registry will remain there indefinitely. It is hoped that this sharing of information will lead to a better understanding of how to best treat patients with GIST.

You and your doctor will decide what treatment you will receive. Because this Registry is only to observe actual medical practice, it does not require you to receive any particular treatment.

Only your doctor and people who will help your doctor collect the information for this Registry will know which information submitted to the Registry belongs to you. Data will be tracked in the Registry using only ID numbers and patient initials. The information submitted on the Registry data collection forms will not be associated with a specific patient's identity. Separately, you will be asked to provide your name, place of birth, and Social Security number. This information will not be entered into the Registry databases and will only be used if it is necessary to perform a search should you become lost to follow up. If you do not want to provide your Social Security number you may still be enrolled in the Registry.

This is an investigational study. About 100 patients from M. D. Anderson will be entered into the Registry. In all, about 1800 patients will be registered. The Registry will be active for at least 7 years.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients diagnosed with a gastrointestinal stromal tumor (GIST).

Gastrointestinal Stromal Tumors
Other: GIST Registry
Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors.
GIST
Patients diagnosed with a gastrointestinal stromal tumor (GIST)
Intervention: Other: GIST Registry
Pisters PW, Blanke CD, von Mehren M, Picus J, Sirulnik A, Stealey E, Trent JC; reGISTry Steering Committee. A USA registry of gastrointestinal stromal tumor patients: changes in practice over time and differences between community and academic practices. Ann Oncol. 2011 Nov;22(11):2523-9. doi: 10.1093/annonc/mdq773. Epub 2011 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

1. All patients who have been diagnosed with GIST are eligible for enrollment.

Exclusion Criteria:

1. Patients with a histologic diagnosis other than gastrointestinal stromal tumor (GIST).

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00507273
2005-0294
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Novartis Pharmaceuticals
Principal Investigator: Jonathon Trent, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP