C15 C16 C17 C18 C48
Conditions
Interventions
Group 1: Day -30 to -1 prior to start of therapy: Screening examination for all participants. A mutational analysis of a histologic sample is performed to detect cKIT- and PDGFR-mutations (inclusion c
Sponsors
Universitätsklinikum Schleswig-Holstein Klinik für Hämatologie und Onkologie Campus Lübeck
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • histologically confirmed GIST and finding of cKIT or PDGFR mutation in tissue • localized, locally advanced or limited metastatic GIST disease • high risk of relapse according to AFIP criteria • planned resection, including local resection and multivisceral resection aiming for complete resection • planned follow-up visits according to the current national guidelines (including standard of care imaging) • = 18 years * Neoadjuvant treatment and adjuvant treatment after resection are allowed after admission.
Exclusion criteria
Exclusion criteria: • locally advanced or metastatic disease not amenable to curative surgery • additional tumor disease in the past 3 years except for cervical carcinoma treated in line with guidelines or basal cell carcinoma and squamous cell carcinoma of the skin • life expectancy < 3 months • lack of cKIT or PDGFRA mutation in tissue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. detection of tumor-specific mutations in ctDNA isolated from plasma after surgical therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. detection of tumor-specific mutations in ctDNA isolated from plasma at diagnosis 2. detection of tumor-specific mutations in ctDNA isolated from plasma before surgical therapy 3. detection of tumor-specific mutations in ctDNA isolated from plasma before neoadjuvant pharmacotherapy 4. dynamic changes in the amount of ctDNA during and after neoadjuvant pharmacotherapy 5. dynamic changes in the amount and composition of ctDNA during trial duration 6. amount of ctDNA/MAF (minor allele frequency) in case of high risk of relapse calculated via AFIP-score 7. changes in the amount of ctDNA/MAF in case of clinically diagnosed progressive disease or relapse 8. changes in the amount of ctDNA/MAF in case of suspected progressive disease or relapse after medical imaging 9. specificity and sensitivity of this biomarker 10. costs of medical imaging versus biomarker diagnostic Assessment of safety: Not applicable (no study-specific therapeutic intervention planned apart from study related blood withdrawals) | — |
Countries
Germany
Contacts
Public ContactEmilia Prieß
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Outcome results
None listed