Gastric GISTNCT04269941
Prognostic Factors Affecting Survival of Gastric GIST
An observational study of Gastric GIST, run by Université de Sousse.
Trial summary
Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Gastric GIST
- What is being tested?
- total or subtotal gastrectomy
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 2 Jan 2018
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There were 34 patients with the mean age of 58.2 years and male predominance. The disease was localized, locally advanced and metastatic in 26, 6 and 2 cases, respectively. Complete surgical resection was performed in 32 cases.
Who may be able to join
- -
Who cannot join
- patient operated for other gastric tumors
About this study
Official title: Clinicopathological Characteristics and Prognostic Factors of Gastrointestinal Stromal Tumors Located in the Stomach in Tunisian Patients
Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. This study aimed to identify the clinicopathological characteristics of gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.
Read the detailed description
The prognosis of gastric GIST depends on various tumor factors with the most important being the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of advanced GIST.
They have been the subject of much controversy in terms of their histogenesis, classification, treatment and prognosis. GISTs are histologically similar to smooth muscle and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well characterized with the recent discovery of the C-KIT gene mutation and the expression by tumor cells of the C-KIT protein.
Moreover, the discovery of this receptor is at the origin of the introduction of a "targeted therapy": an anti-tyrosine kinase molecule having revolutionized the therapeutic management of these tumors. However, the standard curative treatment of GIST remains complete surgical resection with negative margin from the tumor.
- Conditions
- Gastric GIST
- Being tested
- total or subtotal gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total or subtotal gastrectomyOther
resection of the gastric tumor
| Study group | Role | What they receive |
|---|---|---|
| prognostic factors of gastrointestinal stromal tumors | for the patient diagnosed with gastic GIST , they underwent subtotal or total gastrectomy. Receives: Other: total or subtotal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients operated for gastric GIST
the patient having adenocarcinoma or other histopathological type are excluded
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2000
- Primary completion29 Jan 2015
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric GISTStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ammar houssem, Université de Sousse
- Investigators
- ALI BEN ALI, PROFESSOR, Study director, university of sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269941
- Sponsor's protocol ID
- U23453
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological Characteristics and Prognostic Factors of Gastrointestinal Stromal Tumors Located in the Stomach in Tunisian Patients
- ClinicalTrials.gov ID
- NCT04269941
- Acronym / sponsor ID
- U23453
- Conditions
- Gastric GIST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Université de SousseUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 29 Jan 2015 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 17 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.
Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. This study aimed to identify the clinicopathological characteristics of gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.
Detailed description
The prognosis of gastric GIST depends on various tumor factors with the most important being the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of advanced GIST.
They have been the subject of much controversy in terms of their histogenesis, classification, treatment and prognosis. GISTs are histologically similar to smooth muscle and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well characterized with the recent discovery of the C-KIT gene mutation and the expression by tumor cells of the C-KIT protein.
Moreover, the discovery of this receptor is at the origin of the introduction of a "targeted therapy": an anti-tyrosine kinase molecule having revolutionized the therapeutic management of these tumors. However, the standard curative treatment of GIST remains complete surgical resection with negative margin from the tumor.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prognostic factors of gastrointestinal stromal tumors | – | Other: total or subtotal gastrectomyfor the patient diagnosed with gastic GIST , they underwent subtotal or total gastrectomy. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There were 34 patients with the mean age of 58.2 years and male predominance. The disease was localized, locally advanced and metastatic in 26, 6 and 2 cases, respectively. Complete surgical resection was performed in 32 cases.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- patient operated for other gastric tumors
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 |
|---|---|---|
| total or subtotal gastrectomyresection of the gastric tumor | Other | prognostic factors of gastrointestinal stromal tumors |
Primary outcome
number of patients operated for gastric GIST
Time frame: 30 days
the patient having adenocarcinoma or other histopathological type are excluded
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 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
ALI BEN ALI, PROFESSOR study director
university of sousse
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric GIST, run by Université de Sousse.
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 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
number of patients operated for gastric GIST (time frame: 30 days). 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 17 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.