Jejunoileal vs Gastric GIST in the Era of Imatinib.

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923400
• Other study ID #: YiGi
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: April 2019
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Disease-free Survival
• Gastrointestinal Stromal Tumors
• Overall Survival
• Recurrence

Locations

Country	Name	City	State
Spain	David Ferreras	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

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