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Gastrointestinal Stromal Tumors (GIST) Registry

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00507273

First Posted: July 26, 2007

Last Update Posted: August 2, 2012

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.

Collaborator:

Novartis Pharmaceuticals

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Purpose

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	Intervention
Gastrointestinal Stromal Tumors	Other: GIST Registry


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Gastrointestinal Stromal Tumors (GIST) Registry Protocol: reGISTry

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

Genetic and Rare Diseases Information Center resources: Gastrointestinal Stromal Tumors

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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.


Enrollment:	1800
Study Start Date:	August 2005
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
GIST Patients diagnosed with a gastrointestinal stromal tumor (GIST)	Other: GIST Registry Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors.

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with a gastrointestinal stromal tumor (GIST).

Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

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

Locations


United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Novartis Pharmaceuticals

Investigators


Principal Investigator:	Jonathon Trent, MD, PhD	M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507273 History of Changes
Other Study ID Numbers:	2005-0294
First Submitted:	July 25, 2007
First Posted:	July 26, 2007
Last Update Posted:	August 2, 2012
Last Verified:	August 2012

Keywords provided by M.D. Anderson Cancer Center:


Gastrointestinal Stromal Tumors Gastrointestinal Cancer GISTs GIST Registry Registry

Additional relevant MeSH terms:


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

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