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Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo

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ClinicalTrials.gov Identifier: NCT00564265
Recruitment Status : Completed
First Posted : November 27, 2007
Results First Posted : October 21, 2009
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
Cirujanos la Serena

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition Gastrointestinal Stromal Tumors
Intervention Other: Observation
Enrollment 24
Recruitment Details Hospital patients operated on for Gastrointestinal stromal tumor (GIST)
Pre-assignment Details The intention was to include all consecutive patients with GIST who presented during the study period. All consecutive patients with GIST were included during the study period
Arm/Group Title Gastrointestinal Stromal Tumor (GIST)
Hide Arm/Group Description GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Gastrointestinal Stromal Tumor (GIST)
Hide Arm/Group Description GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  91.7%
>=65 years
2
   8.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
49  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
12
  50.0%
Male
12
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Chile Number Analyzed 24 participants
24
1.Primary Outcome
Title Number of Patients Who Survived
Hide Description The outcomes were measured through follow-up visits of the patients to the out-patient clinic of our institution at 15 days, 1 month, 3 months, 6 months, 1 year, and after that, every year after the surgical treatment.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This is a consecutive sample of all patients operated on for GISTs in 3 hospitals during a period of 5 years. The period of 5 years was determined by the time that we count with inmunochemistry to confirm GISTs at our institutions, and that time would be the last 5 years. The Last Observation Carried Dorward (LOCF) was made in August 2008.
Arm/Group Title Gastrointestinal Stromal Tumor (GIST)
Hide Arm/Group Description:
GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
5
Time Frame No adverse events were assessed or collected (0/24)
Adverse Event Reporting Description Adverse events were not assessed (threshold of 0%).
 
Arm/Group Title Gastrointestinal Stromal Tumor (GIST)
Hide Arm/Group Description GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
All-Cause Mortality
Gastrointestinal Stromal Tumor (GIST)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gastrointestinal Stromal Tumor (GIST)
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gastrointestinal Stromal Tumor (GIST)
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Marcelo A. Beltran
Organization: Hospital de La Serena
Phone: 56 - 51 - 485923
EMail: beltran_01@yahoo.com
Layout table for additonal information
Responsible Party: Sobelcru Ltda
ClinicalTrials.gov Identifier: NCT00564265     History of Changes
Other Study ID Numbers: HLS-0047-11-07
0047-11-07
First Submitted: November 26, 2007
First Posted: November 27, 2007
Results First Submitted: November 3, 2008
Results First Posted: October 21, 2009
Last Update Posted: August 11, 2011