Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)

Technical University of Munich

Status and phase

Completed

Phase 3

Conditions

Gastrointestinal Stromal Tumors

Treatments

Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years

Study type

Interventional

Funder types

Other

Identifiers

NCT01462994

CSTI571BDE78T

Details and patient eligibility

About

Activating mutations of the kinases CKIT or PDGFRA can be detected in 90% of cases by DNA sequence analysis of a pathological specimen. These mutated genomic DNA fragments are highly specific for the tumor and are released by the tumor into the circulation. Allele-specific PCR can be used to specifically amplify and quantify mutated CKIT and PDGFR DNA fragments.

The current trial aims to evaluate whether tumor DNA carrying mutations for CKIT and PDGFRA can be detected and quantified in the plasma of patients with active GIST, and whether detection can be correlated with the clinical course of disease either under therapy or in progressive disease irrespective of current therapy.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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