Gastro Intestinal Stromal TumorMETAGISTNCT03963544
Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (METAGIST)
An observational study of Gastro Intestinal Stromal Tumor, run by Institut Bergonié at 1 site in France.
Trial summary
Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Stromal Tumor
- What is being tested?
- oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations
- Type of treatment
- Pill or oral medicine
- How many people
- 492 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1990to Dec 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: metastatic Gastrointestinal Stromal Tumor
Who may be able to join
- patients ≥ 18 years old
- with a diagnosis of metastatic Gastrointestinal Stromal Tumor (metastatic at diagnostic or metastatic relapse)
- From 1990 to 2018
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (GIST) in a Real-life Setting: the METAGIST Observational Study
Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Treatment of localized forms relies on adequate surgery without tumor spillage and systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as Imatinib, Sunitinib and Regorafenib. Over two decades significant changes in drug discovery have impacted treatment strategies, notably via patient's access to various clinical trials. The use of focal treatments such as surgery or interventional radiology with mini invasive procedure of oligometastasis is also being proposed in some cases.
There is no precise data on patterns of sequential treatments used, especially proportions of patients with metastatic GIST eventually benefiting from access to a clinical trial or a focal treatment strategy in the course of their disease, and their results in terms of survival on a real life national level.
Read more
Using the French sarcoma Group national database we aim at describing treatments strategies proposed patients with metastatic GIST in the real life setting.
Objectives include : (i) Description of clinico-biological profiles, patterns of care and modalities of treatment of patients with metastatic GIST in a real-life national setting and (ii) evaluation of patients outcome in terms of time to next treatment (TNT) and survival
- Conditions
- Gastro Intestinal Stromal Tumor
- Being tested
- oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendationsDrug
oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Next Treatment (TNT)
time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.
Measured: 10 years
Overall Survival (OS) Time
the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.
Measured: 10 years
Secondary outcomes (2)
Treatment With a Systemic Therapy
Proportion of metastatic patients treated with a systemic therapy
Measured: At diagnosis of metastatic disease
Proportion of Participants Included in a Clinical Trial
Proportion of participants included in a clinical trial (other than the present study) during the course of their metastatic disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study startJan 1990
- Primary completionSep 2024
- Study completionDec 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro Intestinal 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
- Prospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- French Sarcoma Group
- Responsible party
- Sponsor
- Investigators
- Maud Toulmonde, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963544
- Sponsor's protocol ID
- IB2019-METAGIST
- Acronym
- METAGIST
- Status last verified
- Nov 2025
- First submitted
- 23 May 2019
- Last updated
- 10 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Toulmonde M, Dinart D, Brahmi M, Verret B, Jean-Denis M, Ducimetiere F, Desolneux G, Meeus P, Palussiere J, Buy X, Bouhamama A, Gillon P, Dufresne A, Henon C, Le Loarer F, Karanian M, Ngo C, Mathoulin-Pelissier S, Bellera C, Le Cesne A, Blay JY, Italiano A. Evolution of Patterns of Care and Outcomes in the Real-Life Setting for Patients with Metastatic GIST Treated in Three French Expert Centers over Three Decades. Cancers (Basel). 2023 Aug 28;15(17):4306. doi: 10.3390/cancers15174306.
PubMed 37686582
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Care and Outcomes of Patients With METAstatic Gastrointestinal Stromal Tumors (GIST) in a Real-life Setting: the METAGIST Observational Study
- ClinicalTrials.gov ID
- NCT03963544
- Acronym / sponsor ID
- METAGIST / IB2019-METAGIST
- Conditions
- Gastro Intestinal Stromal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- French Sarcoma Group
- Study start
- Jan 1990 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 10 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastro intestinal stromal tumors (GIST) are rare mesenchymal tumors of the gastrointestinal tract characterized by somatic mutations in the gene encoding the KIT or the PDGFR alpha protein1. Treatment of localized forms relies on adequate surgery without tumor spillage and systemic treatment with imatinib according to risk of relapse defined by localization, tumor size and mitotic count, as well as mutational status. Advanced and relapsing forms are currently treated with oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR such as Imatinib, Sunitinib and Regorafenib. Over two decades significant changes in drug discovery have impacted treatment strategies, notably via patient's access to various clinical trials. The use of focal treatments such as surgery or interventional radiology with mini invasive procedure of oligometastasis is also being proposed in some cases.
There is no precise data on patterns of sequential treatments used, especially proportions of patients with metastatic GIST eventually benefiting from access to a clinical trial or a focal treatment strategy in the course of their disease, and their results in terms of survival on a real life national level.
Using the French sarcoma Group national database we aim at describing treatments strategies proposed patients with metastatic GIST in the real life setting.
Objectives include : (i) Description of clinico-biological profiles, patterns of care and modalities of treatment of patients with metastatic GIST in a real-life national setting and (ii) evaluation of patients outcome in terms of time to next treatment (TNT) and survival
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- metastatic Gastrointestinal Stromal Tumor
Key inclusion criteria (3 listed)
- patients ≥ 18 years old
- with a diagnosis of metastatic Gastrointestinal Stromal Tumor (metastatic at diagnostic or metastatic relapse)
- From 1990 to 2018
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendationsoral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR | Drug | – |
Primary outcome
Time to Next Treatment (TNT)
Time frame: 10 years
time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.
Overall Survival (OS) Time
Time frame: 10 years
the interval between the diagnosis of metastatic disease or the first-line systemic therapy onset and the time of death.
2 secondary outcomes
Treatment With a Systemic Therapy
Time frame: At diagnosis of metastatic disease
Proportion of Participants Included in a Clinical Trial
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37686582Toulmonde M, Dinart D, Brahmi M, Verret B, Jean-Denis M, Ducimetiere F, Desolneux G, Meeus P, Palussiere J, Buy X, Bouhamama A, Gillon P, Dufresne A, Henon C, Le Loarer F, Karanian M, Ngo C, Mathoulin-Pelissier S, Bellera C, Le Cesne A, Blay JY, Italiano A. Evolution of Patterns of Care and Outcomes in the Real-Life Setting for Patients with Metastatic GIST Treated in Three French Expert Centers over Three Decades. Cancers (Basel). 2023 Aug 28;15(17):4306. doi: 10.3390/cancers15174306.
- 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.
Maud Toulmonde, MD principal investigator
Institut Bergonié
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 Gastro Intestinal Stromal Tumor, run by Institut Bergonié at 1 site in France.
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 3 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 10 Dec 2025. 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 France. 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 10 Dec 2025). 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?
Time to Next Treatment (TNT) (time frame: 10 years). The study lists 2 primary outcomes in all. 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 NCT03963544, which also lists 1 linked publication.
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 10 Dec 2025.