Gastrointestinal Stromal TumorsNCT00564265

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

An observational study of Gastrointestinal Stromal Tumors, run by Cirujanos la Serena at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a retrospective analysis and description of the preferred diagnostic and treatment methods employed on GIST on the Region of Coquimbo from 2003 to 2008. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Gastrointestinal Stromal Tumors
What is being tested?: Observation
How many people: 24 participants
Where: 1 siteChile
Study dates: Jan 2008to Aug 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All patients operated on for GIST

Who may be able to join

All operated patients with GIST
Positive immunohistochemistry

Who cannot join

Patients with GIST not operated
Patients with GIST operated on but without immunohistochemistry

Trial locations and contacts

1 site in 1 country.

Chile1 site

Hospital De La Serena
La Serena, Coquimbo Region

Other trials in Chile

About this study

Official title: Outcomes of Surgical Treatment of Gastrointestinal Stromal Tumors in the IV Region of Chile

This is a retrospective analysis and description of the preferred diagnostic and treatment methods employed on GIST on the Region of Coquimbo from 2003 to 2008.

Conditions: Gastrointestinal Stromal Tumors
Being tested: Observation
Keywords: GIST
Medical subject headings: Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ObservationOther
Not applied

Study groups in NCT00564265
Study group	Role	What they receive
GIST		GIST from all gastrointestinal origins: esophagus, stomach, duodenum, jejunum, ileum, colon and rectum Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients Who Survived
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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Aug 2008

First posted27 Nov 2007 (estimated)
Study startJan 2008
Primary completionJun 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00564265
Sponsor's protocol ID: HLS-0047-11-07
Other IDs: 0047-11-07
Status last verified: Sep 2010
First submitted: 26 Nov 2007
Last updated: 11 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastrointestinal Stromal Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes of Surgical Treatment of Gastrointestinal Stromal Tumors in the IV Region of Chile
ClinicalTrials.gov ID: NCT00564265
Acronym / sponsor ID: HLS-0047-11-07
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST
Study type: Observational
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Cirujanos la SerenaUniversity, hospital or other
Study start: Jan 2008
Primary completion: Jun 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 27 Nov 2007 (estimated)
Results: Posted 21 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a retrospective analysis and description of the preferred diagnostic and treatment methods employed on GIST on the Region of Coquimbo from 2003 to 2008.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
GIST	–	Other: ObservationGIST from all gastrointestinal origins: esophagus, stomach, duodenum, jejunum, ileum, colon and rectum

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All patients operated on for GIST

Key inclusion criteria (2 listed)

All operated patients with GIST
Positive immunohistochemistry

Key exclusion criteria (2 listed)

Patients with GIST not operated
Patients with GIST operated on but without immunohistochemistry

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ObservationNot applied	Other	GIST

Primary outcome

Number of Patients Who Survived
Time frame: 5 years
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.

Results and safety

Results posted to the registry on 21 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gastrointestinal Stromal Tumor (GIST)	24	24

Primary outcome: Number of Patients Who Survived

Time frame: 5 years. Number. Unit: Participants

Measure	Gastrointestinal Stromal Tumor (GIST) n = 24
Value	5

Population analysed: 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.

Adverse events

Time frame: No adverse events were assessed or collected (0/24). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gastrointestinal Stromal Tumor (GIST)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Revista Chilena de Cirugia, 2011; 63:290-296Link provided by the sponsor.

Related trials for Gastrointestinal Stromal Tumors

RecruitingObservational study
A Patient-Derived 3D Bioprinted Colorectal Cancer-Stroma-Immune Triad Model Uncovers Microenvironmental Mechanisms of Chemoresistance and Immune Evasion
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RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
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RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
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A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcelo A Beltran, MD principal investigator

Hospital de La Serena

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Stromal Tumors, run by Cirujanos la Serena at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Who Survived (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00564265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.