Gastrointestinal Stromal Tumors (GIST) Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00507273 |
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Recruitment Status :
Completed
First Posted : July 26, 2007
Last Update Posted : August 2, 2012
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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:
- To describe variation in management of patients with GIST, overall and by patient and provider characteristics.
- 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Gastrointestinal Stromal Tumors | Other: GIST 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.
| Study Type : | Observational |
| Actual Enrollment : | 1800 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Gastrointestinal Stromal Tumors (GIST) Registry Protocol: reGISTry |
| Study Start Date : | August 2005 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Group/Cohort | Intervention/treatment |
|---|---|
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GIST
Patients diagnosed with a gastrointestinal stromal tumor (GIST)
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Other: GIST Registry
Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors. |
- Current patterns of medical practice in management of patients with GIS [ Time Frame: 5 Years ]Data from observational GIST Registry analyzed to describe current patterns.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507273
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jonathon Trent, MD, PhD | M.D. Anderson Cancer Center |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00507273 History of Changes |
| Other Study ID Numbers: |
2005-0294 |
| First Posted: | July 26, 2007 Key Record Dates |
| Last Update Posted: | August 2, 2012 |
| Last Verified: | August 2012 |
Keywords provided by M.D. Anderson Cancer Center:
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Gastrointestinal Stromal Tumors Gastrointestinal Cancer GISTs GIST Registry Registry |
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |