Gastrointestinal Stromal TumorNCT04256226
Clinical Outcome of Female Non-gastric Gastrointestinal Stromal Tumor
An observational study of Gastrointestinal Stromal Tumor, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- Tumor excision
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 31 Mar 2020
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: non-gastric gastrointestinal tumor in women
Who may be able to join
- > 20 years of women.
- non-gastric gastrointestinal stromal tumor
Who cannot join
- Those without pathological report or surgical record.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
About this study
Official title: Far Eastern Memorial Hospital
To elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.
Read the detailed description
Gastrointestinal stromal tumor (GIST) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. They took up about 3% of gastrointestinal malignancies. Although rarely, the clinical presentation of non-gastric GIST might mimick ovarian cancer, and would be managed by gynecologists. Therefore, retrospective review of female non-gastric GIST cases will be performed to investigate the clinical outcome of non-gastric GIST. The result of this study might be used as an important reference for gynecologists.
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- Tumor excision
- 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.
Tumor excisionProcedure or surgery
Excision of GIST
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The date of surgery to the date of death or last follow-up
Measured: 20 years
Secondary outcomes (1)
Recurrence-free survival
The date of surgery to the date of recurrence or last follow-up
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256226
- Sponsor's protocol ID
- 108174-E
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT04256226
- Acronym / sponsor ID
- 108174-E
- Conditions
- Gastrointestinal Stromal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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 elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.
Detailed description
Gastrointestinal stromal tumor (GIST) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. They took up about 3% of gastrointestinal malignancies. Although rarely, the clinical presentation of non-gastric GIST might mimick ovarian cancer, and would be managed by gynecologists. Therefore, retrospective review of female non-gastric GIST cases will be performed to investigate the clinical outcome of non-gastric GIST. The result of this study might be used as an important reference for gynecologists.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-gastric gastrointestinal tumor in women
Key inclusion criteria (2 listed)
- > 20 years of women.
- non-gastric gastrointestinal stromal tumor
Key exclusion criteria (1 listed)
- Those without pathological report or surgical record.
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 |
|---|---|---|
| Tumor excisionExcision of GIST | Procedure or surgery | – |
Primary outcome
Overall survival
Time frame: 20 years
The date of surgery to the date of death or last follow-up
1 secondary outcome
Recurrence-free survival
Time frame: 20 years
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 2 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tumor, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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 2 Jun 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 Taiwan. 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.
What does the primary outcome measure?
Overall survival (time frame: 20 years). It is what the study was designed to measure, not a finding.
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 2 Jun 2020.