Jejunoileal vs Gastric GIST in the Era of Imatinib.

NCT03923400 | Completed

• 1 other identifier: YiGi
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disease-free Survival; Overall Survival; Recurrence

Keywords

GIST; small bowel; jejunum; ileum

Outcome Measures

Primary Outcomes (7)

• KIT Gene mutation

  Number of patients with a molecular analysis positive for KIT mutation

  15 years

• PDGFRA Gene mutation

  Number of patients with a molecular analysis positive for PDGFRA mutation

  15 years

• Expression of CD117

  Number of patients with immunohistochemical expression of CD117

  15 years

• Expression of DOG1

  Number of patients with immunohistochemical expression of DOG1

  15 years

• Recurrence

  Number of patients with recurrence after treatment with tyrosinkin inhibitors.

  15 years

• Deceased

  Number of patients deceased during follow-up.

  15 years

• Location

  Location of the tumor (gastric o jejunoileal)

  15 years

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Virgen de la Arrixaca: lead

Study Sites (1)

David Ferreras

Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 22, 2019
• Study Start: November 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

ES (1)