Gastrointestinal Stromal Tumors (GIST) Registry

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Gastrointestinal Stromal Tumors (GIST) Registry Protocol: reGISTry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507273
• Other study ID #: 2005-0294
• Status: Completed
• Phase: N/A
• First received: July 25, 2007
• Last updated: August 1, 2012
• Start date: August 2005
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Other:
• GIST Registry
Internet based data registry about how different physicians treat and manage patients with gastrointestinal stromal tumors.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current patterns of medical practice in management of patients with GIS	Data from observational GIST Registry analyzed to describe current patterns.	5 Years	No

External Links

•   UT MD Anderson Cancer Center