Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01462994
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Male or female patients aged \>= 18 years
* Histologically confirmed GIST
* Known activating mutation of CKIT or PDGFRA and tissue sample can be provided for central mutation analysis or mutation status unknown and tissue sample can be provided for central mutation analysis at baseline
* Routinely planned follow-up visits in no longer than three months intervals (+ 14 days) including local standard of care diagnostic imaging (CT, PET- CT, or MRI)
* At least one GIST lesion that can be measured by CT, PET-CT, or MRI
* Planned surgery of one or more disease manifestations or planned TKI treatment (such as imatinib or sunitinib) in neoadjuvant or palliative intention or disease progression irrespective of current/planned treatment
* Life expectancy of at least three months
Exclusion Criteria:
* Wild type sequence for CKIT exon 9, 11, 13, 14, 17, 18 and PDGFRA exon 18
* Tissue sample can not be provided for central mutation analysis
* Surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions
* Patients currently receiving adjuvant TKI treatment after surgery and no evidence of progressive lesions
* Patients currently receiving palliative TKI treatment and no evidence of progressive lesions
* Planned follow-up intervals including CT, PET-CT or MRI at more than three months intervals (+ 14 days)
* Coexisting medical condition or treatment that could interfere with the ability of the patient to comply with planned treatment interventions (surgery or TKI treatment) or regular follow-up visits
* Patients unwilling to or unable to comply with the planned therapeutic intervention (surgery or TKI treatment) or to comply with the regular follow-up visits including blood sample collection
* Pregnancy and lactation
* Presence of chronic inflammatory diseases, autoimmune diseases, or liver cirrhosis
* Known HIV and/or hepatitis B or C infection
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01462994
Study Brief:
Protocol Section:
NCT01462994