Gastrointestinal stromal tumors: assessment of mutations in tumors and in circulating tumor DNA and measurement of TKI plasma exposure to optimize treatment
Recruiting
- Conditions
- Gastrointestinal stromal tumor10072990
- Registration Number
- NL-OMON40778
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
- Patients diagnosed with a GIST with an indication to be treated with a TKI of whom a histological biopsy before start treatment is available.
- Informed consent is given
Exclusion Criteria
- Patients of whom no tumor is available before start of first line TKI
- Patients that refuse a tumor biopsy in case of tumor progression
- Patients in whom it will not be possible to perform a biopsy in case of tumor progression (for example anti-coagulants that cannot be interrupted).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Detection of secondary GIST mutations in circulating tumor DNA of patients<br /><br>with progressive disease (according to RECIST 1.1 on computer tomography), that<br /><br>are not present in patients that have no progressive disease after the same<br /><br>time of treatment with imatinib<br /><br>• Investigate whether these secondary mutations can be detected months before<br /><br>progressive disease is assessed according to RECIST 1.1 on computer tomography<br /><br>• Investigate whether progression free survival is influenced by imatinib<br /><br>plasma concentration levels </p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>