Disease-free SurvivalNCT03923400
Jejunoileal vs Gastric GIST in the Era of Imatinib.
An observational study of Disease-free Survival and Overall Survival, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease-free Survival, Overall Survival, Recurrence
- How many people
- 77 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2016to 31 Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GIST diagnosis was established by an experienced board-certified pathologist who reviewed our database prospectively maintained. After revision, we included in the study any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST. The patients were divided into two groups: patients with GISTs located in the jejunum or ileum, comprising the JI-GIST group; and patients with gastric GISTs, comprising the G-GIST group.
Who may be able to join
- Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics and Prognosis of Jejunoileal Gastrointestinal Stromal Tumors (GISTs) in the Era of Imatinib. A Comparative Retrospective Study With Gastric GISTs.
Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.
Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.
- Conditions
- Disease-free Survival, Overall Survival, Recurrence
- Keywords
- GIST, small bowel, jejunum, ileum
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| JI-GIST | The series comprises 77 patients, of which 29 (37.7%) were located in the jejunum or ileum (JI-GIST). | |
| G-GIST | The series comprises 77 patients, of which 48 (62.3%) were located in the stomach (G-GIST). |
What is being measured
The primary outcome is the main question the study is designed to answer.
KIT Gene mutation
Number of patients with a molecular analysis positive for KIT mutation
Measured: 15 years
PDGFRA Gene mutation
Number of patients with a molecular analysis positive for PDGFRA mutation
Measured: 15 years
Expression of CD117
Number of patients with immunohistochemical expression of CD117
Measured: 15 years
Expression of DOG1
Number of patients with immunohistochemical expression of DOG1
Measured: 15 years
Recurrence
Number of patients with recurrence after treatment with tyrosinkin inhibitors.
Measured: 15 years
Deceased
Number of patients deceased during follow-up.
Measured: 15 years
Location
Location of the tumor (gastric o jejunoileal)
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Nov 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease-free SurvivalStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ferreras, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923400
- Sponsor's protocol ID
- YiGi
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 22 Apr 2019
- 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 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Prognosis of Jejunoileal Gastrointestinal Stromal Tumors (GISTs) in the Era of Imatinib. A Comparative Retrospective Study With Gastric GISTs.
- ClinicalTrials.gov ID
- NCT03923400
- Acronym / sponsor ID
- YiGi
- Conditions
- Disease-free Survival, Overall Survival, Recurrence
- Keywords
- GIST, small bowel, jejunum, ileum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 22 Apr 2019 (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.
Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.
Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JI-GIST | – | –The series comprises 77 patients, of which 29 (37.7%) were located in the jejunum or ileum (JI-GIST). |
| G-GIST | – | –The series comprises 77 patients, of which 48 (62.3%) were located in the stomach (G-GIST). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GIST diagnosis was established by an experienced board-certified pathologist who reviewed our database prospectively maintained. After revision, we included in the study any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST. The patients were divided into two groups: patients with GISTs located in the jejunum or ileum, comprising the JI-GIST group; and patients with gastric GISTs, comprising the G-GIST group.
Key inclusion criteria (1 listed)
- Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.
Key exclusion criteria (1 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
KIT Gene mutation
Time frame: 15 years
Number of patients with a molecular analysis positive for KIT mutation
PDGFRA Gene mutation
Time frame: 15 years
Number of patients with a molecular analysis positive for PDGFRA mutation
Expression of CD117
Time frame: 15 years
Number of patients with immunohistochemical expression of CD117
Expression of DOG1
Time frame: 15 years
Number of patients with immunohistochemical expression of DOG1
Recurrence
Time frame: 15 years
Number of patients with recurrence after treatment with tyrosinkin inhibitors.
Deceased
Time frame: 15 years
Number of patients deceased during follow-up.
Location
Time frame: 15 years
Location of the tumor (gastric o jejunoileal)
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 22 Apr 2019.
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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 Disease-free Survival and Overall Survival, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 22 Apr 2019. 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 Spain. 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?
KIT Gene mutation (time frame: 15 years). The study lists 7 primary outcomes in all. 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 22 Apr 2019.