Trial Outcomes & Findings for Current Management of Gastrointestinal Stromal Tumors (GIST) in the Region of Coquimbo (NCT NCT00564265)

NCT ID: NCT00564265

Last Updated: 2011-08-11

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

5 years

Results posted on

2011-08-11

Participant Flow

Hospital patients operated on for Gastrointestinal stromal tumor (GIST)

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

Participant milestones

Participant milestones
Measure
Gastrointestinal Stromal Tumor (GIST)
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 Study
STARTED
24
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Gastrointestinal Stromal Tumor (GIST)
n=24 Participants
GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
22 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
Age Continuous
49 years
STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Region of Enrollment
Chile
24 participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Gastrointestinal Stromal Tumor (GIST)
n=24 Participants
GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
Number of Patients Who Survived
5 Participants

Adverse Events

Gastrointestinal Stromal Tumor (GIST)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marcelo A. Beltran

Hospital de La Serena

Phone: 56 - 51 - 485923

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place