Jejunoileal vs Gastric GIST in the Era of Imatinib.

April 18, 2019 updated by: David Ferreras, Hospital Universitario Virgen de la Arrixaca

Characteristics and Prognosis of Jejunoileal Gastrointestinal Stromal Tumors (GISTs) in the Era of Imatinib. A Comparative Retrospective Study With Gastric GISTs.

Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.

Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • David Ferreras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

GIST diagnosis was established by an experienced board-certified pathologist who reviewed our database prospectively maintained. After revision, we included in the study any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST. The patients were divided into two groups: patients with GISTs located in the jejunum or ileum, comprising the JI-GIST group; and patients with gastric GISTs, comprising the G-GIST group.

Description

Inclusion Criteria:

  • Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
JI-GIST
The series comprises 77 patients, of which 29 (37.7%) were located in the jejunum or ileum (JI-GIST).
G-GIST
The series comprises 77 patients, of which 48 (62.3%) were located in the stomach (G-GIST).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KIT Gene mutation
Time Frame: 15 years
Number of patients with a molecular analysis positive for KIT mutation
15 years
PDGFRA Gene mutation
Time Frame: 15 years
Number of patients with a molecular analysis positive for PDGFRA mutation
15 years
Expression of CD117
Time Frame: 15 years
Number of patients with immunohistochemical expression of CD117
15 years
Expression of DOG1
Time Frame: 15 years
Number of patients with immunohistochemical expression of DOG1
15 years
Recurrence
Time Frame: 15 years
Number of patients with recurrence after treatment with tyrosinkin inhibitors.
15 years
Deceased
Time Frame: 15 years
Number of patients deceased during follow-up.
15 years
Location
Time Frame: 15 years
Location of the tumor (gastric o jejunoileal)
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YiGi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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