Prognostic Factors Affecting Survival of Gastric GIST

Sponsor

Université de Sousse (Other)

Overall Status

Completed

CT.gov ID

NCT04269941

Collaborator

(none)

Enrollment

216

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. This study aimed to identify the clinicopathological characteristics of gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.

Condition or Disease	Intervention/Treatment	Phase
Gastric GIST	Other: total or subtotal gastrectomy

Detailed Description

The prognosis of gastric GIST depends on various tumor factors with the most important being the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of advanced GIST.

They have been the subject of much controversy in terms of their histogenesis, classification, treatment and prognosis. GISTs are histologically similar to smooth muscle and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well characterized with the recent discovery of the C-KIT gene mutation and the expression by tumor cells of the C-KIT protein.

Moreover, the discovery of this receptor is at the origin of the introduction of a "targeted therapy": an anti-tyrosine kinase molecule having revolutionized the therapeutic management of these tumors. However, the standard curative treatment of GIST remains complete surgical resection with negative margin from the tumor.

Study Design

Study Type:

Observational

Actual Enrollment :

34 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Clinicopathological Characteristics and Prognostic Factors of Gastrointestinal Stromal Tumors Located in the Stomach in Tunisian Patients

Actual Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Jan 29, 2015

Actual Study Completion Date :

Jan 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
prognostic factors of gastrointestinal stromal tumors for the patient diagnosed with gastic GIST , they underwent subtotal or total gastrectomy.	Other: total or subtotal gastrectomy resection of the gastric tumor

Arm

Intervention/Treatment

prognostic factors of gastrointestinal stromal tumors

for the patient diagnosed with gastic GIST , they underwent subtotal or total gastrectomy.

Other: total or subtotal gastrectomy

resection of the gastric tumor

Outcome Measures

Primary Outcome Measures

number of patients operated for gastric GIST [30 days]
the patient having adenocarcinoma or other histopathological type are excluded

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: patient having gastric GIST

Exclusion Criteria:

patient operated for other gastric tumors

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Université de Sousse

Investigators

Study Director: ALI BEN ALI, PROFESSOR, university of sousse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ammar houssem, Doctor, Université de Sousse

ClinicalTrials.gov Identifier:

NCT04269941

Other Study ID Numbers:

U23453

First Posted:

Feb 17, 2020

Last Update Posted:

Feb 17, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 17, 2020