Gastrointestinal stromal tumors: assessment of mutations in tumors and in circulating tumor DNA and measurement of TKI plasma exposure to optimize treatment

Gastrointestinal stromal tumors: assessment of mutations in tumors and in circulating tumor DNA and measurement of TKI plasma exposure to optimize treatment - GIST: assessment of tumor mutations and TKI plasma exposure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40778

Enrollment

600

Registered

2014-11-25

Start date

2014-12-08

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal stromal tumor

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Patients of whom no tumor is available before start of first line TKI

Design outcomes

Primary

Measure	Time frame
• Detection of secondary GIST mutations in circulating tumor DNA of patients with progressive disease (according to RECIST 1.1 on computer tomography), that are not present in patients that have no progressive disease after the same time of treatment with imatinib • Investigate whether these secondary mutations can be detected months before progressive disease is assessed according to RECIST 1.1 on computer tomography • Investigate whether progression free survival is influenced by imatinib plasma concentration levels	—

Measure

Time frame

• Detection of secondary GIST mutations in circulating tumor DNA of patients with progressive disease (according to RECIST 1.1 on computer tomography), that are not present in patients that have no progressive disease after the same time of treatment with imatinib • Investigate whether these secondary mutations can be detected months before progressive disease is assessed according to RECIST 1.1 on computer tomography • Investigate whether progression free survival is influenced by imatinib plasma concentration levels

—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results