Gastrointestinal Stromal Tumors (GIST) Registry - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Novartis
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507273

Purpose

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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

Primary Outcome Measures:

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). [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Groups/Cohorts	Assigned Interventions
1 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 75 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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with a gastrointestinal stromal tumor (GIST).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507273

Contacts

Contact: Jonathon Trent, MD, PhD

713-792-3626

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jonathon Trent, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Novartis

Investigators

Principal Investigator:

Jonathon Trent, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

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

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Jonathan Trent, MD, PhD/Assistant Professor )
Study ID Numbers:	2005-0294
Study First Received:	July 25, 2007
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00507273
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Gastrointestinal Stromal Tumors
Gastrointestinal Cancer
GIST Registry
Registry

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009