Gastrointestinal Stromal TumorsNCT00718211
A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore
An observational study of Gastrointestinal Stromal Tumors, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- May 2006to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: To review medical records of all patients diagnosed with the disease at the two specified centres. The medical records will be obtained through both paper and electronic medical systems. All data will be contained in a password secured database and will be securely located behind institutional firewalls.
Who may be able to join
- Patients diagnosed with Gastrointestinal stromal tumor.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore.
To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore
Read the detailed description
A retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (GIST) in the two tertiary centres in Singapore i.e. Singapore General Hospital and National University Hospital.
Gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. Remarkable progress has been made during the last several years in the diagnosis and treatment of GIST. Understanding of the molecular pathogenesis of GIST which is linked to deregulated KIT tyrosine-kinase activity has improved diagnosis, such that GIST is now more frequently and specifically identified. More importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of GIST patients with advanced or unresectable disease.
GIST has been reviewed in the Western literature but there is a lack of Asian data. The review will help us to better understand the disease in our population.Furthermore we will also examine several unresolved issues in the Western literature by looking into our local data. These include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies.
The medical records of all patients diagnosed with the disease at the two centres will be reviewed.
Analysis of the results aims to:
- to compare the characteristics of the GIST (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature.
- to compare the treatment regimen and results of our centres compared to others
- to review the role of chemotherapy in the adjuvant settings in the centres.
- Conditions
- Gastrointestinal Stromal Tumors
- Medical subject headings
- Gastrointestinal Stromal Tumors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startMay 2006
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ross Andrew Soo, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718211
- Sponsor's protocol ID
- GA01/12/06
- Status last verified
- Jan 2014
- First submitted
- 15 Jul 2008
- Last updated
- 30 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Clinical Records Review of Patients Diagnosed With Gastrointestinal Stromal Tumour at Two Tertiary Institutes in Singapore.
- ClinicalTrials.gov ID
- NCT00718211
- Acronym / sponsor ID
- GA01/12/06
- Conditions
- Gastrointestinal Stromal Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Sep 2013 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in Singapore
Detailed description
A retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (GIST) in the two tertiary centres in Singapore i.e. Singapore General Hospital and National University Hospital.
Gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. Remarkable progress has been made during the last several years in the diagnosis and treatment of GIST. Understanding of the molecular pathogenesis of GIST which is linked to deregulated KIT tyrosine-kinase activity has improved diagnosis, such that GIST is now more frequently and specifically identified. More importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of GIST patients with advanced or unresectable disease.
GIST has been reviewed in the Western literature but there is a lack of Asian data. The review will help us to better understand the disease in our population.Furthermore we will also examine several unresolved issues in the Western literature by looking into our local data. These include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies.
The medical records of all patients diagnosed with the disease at the two centres will be reviewed.
Analysis of the results aims to:
- to compare the characteristics of the GIST (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature.
- to compare the treatment regimen and results of our centres compared to others
- to review the role of chemotherapy in the adjuvant settings in the centres.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- To review medical records of all patients diagnosed with the disease at the two specified centres. The medical records will be obtained through both paper and electronic medical systems. All data will be contained in a password secured database and will be securely located behind institutional firewalls.
Key inclusion criteria (1 listed)
- Patients diagnosed with Gastrointestinal stromal tumor.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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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.
Ross Andrew Soo, MBBS principal investigator
National University Hospital, Singapore
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 National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 0 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 30 Mar 2020. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 30 Mar 2020.