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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01462994
First received: October 25, 2011
Last updated: December 10, 2012
Last verified: December 2012

October 25, 2011
December 10, 2012
November 2011
December 2014   (final data collection date for primary outcome measure)
Percentage of patients with histologically proven GIST, measurable lesion in imaging and activating CKIT and PDGFRA mutation, where detection of tumor specific DNA encoding for mutated CKIT or PDGFA is possible in the plasma at least at one timepoint [ Designated as safety issue: No ]
Percentage of patients with histologically proven GIST, measurable lesion in imaging and activating CKIT and PDGFRA mutation, where detection of tumor specific DNA encoding for mutated CKIT or PDGFA is possible in the plasma at least at one timepoint
Complete list of historical versions of study NCT01462994 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)
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 Treatment. An Open-label, Non-randomized, Multicenter Phase IIIb Clinical Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Gastrointestinal Stromal Tumors
Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years
No Intervention: Single arm
Intervention: Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nikolas von Bubnoff, PD Dr. +49-89-4140 ext 5835 n.bubnoff@lrz.tum.de
Germany
 
NCT01462994
CSTI571BDE78T
No
Technische Universität München
Technische Universität München
Not Provided
Study Chair: Nikolas von Bubnoff, PD Dr. Klinikum rechts der Isar
Technische Universität München
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP