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

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ClinicalTrials.gov Identifier: NCT01462994
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : November 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Single arm Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years


Outcome Measures
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Primary Outcome Measures :
  1. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462994


Locations
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Germany
Klinikum rechts der Isar - III. Medizinische Klinik und Poliklinik
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Study Chair: Nikolas von Bubnoff, PD Dr. Klinikum rechts der Isar
More Information
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01462994    
Other Study ID Numbers: CSTI571BDE78T
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Technische Universität München:
Patients with GIST treated with standard therapy harboring activating mutations of CKIT and PDGFRA
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases