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Clinical Trials/EUCTR2011-002544-27-DE
EUCTR2011-002544-27-DE
Active, not recruiting
Phase 1

Prospective, explorative trial for the detection of circulating cell-free tumor DNA in the plasma of patients with gastrointestinal stromal tumors (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a tyrosine kinase inhibitor or progressive disease irrespective of current or planned treatmentAn open-label, non-randomized, multicenter phase IIIb clinical trial - CF DNA GIST

Technische Universitaet Muenchen Fakultaet fuer Medizin0 sitesSeptember 6, 2011
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ConditionsPatients with gastrointestinal stromal tumor (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a Tyrokinase Inhibitors or progressive disease irrespective of current or planned treatment.Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with gastrointestinal stromal tumor (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a Tyrokinase Inhibitors or progressive disease irrespective of current or planned treatment.
Sponsor
Technische Universitaet Muenchen Fakultaet fuer Medizin
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Technische Universitaet Muenchen Fakultaet fuer Medizin

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 ir\-respective of current/planned treatment
  • •Life expectancy of at least three months
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

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 sur\-gery 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 sam\-ple collection
  • •Pregnancy and lactation
  • •Presence of chronic inflammatory diseases, autoimmune dis\-eases, or liver cirrhosis

Outcomes

Primary Outcomes

Not specified

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