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Gastrointestinal Stromal Tumors (GIST) Registry Protocol: reGISTry

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Gastrointestinal Stromal Tumors

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Trial Information

Gastrointestinal Stromal Tumors (GIST) Registry Protocol: 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

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.

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).

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Current patterns of medical practice in management of patients with GIS

Outcome Description:

Data from observational GIST Registry analyzed to describe current patterns.

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Jonathon Trent, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

December 2010

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Cancer
  • GISTs
  • GIST Registry
  • Registry
  • Gastrointestinal Stromal Tumors



UT MD Anderson Cancer Center Houston, Texas  77030