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
  Purpose

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 Intervention 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Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years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 Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Single arm Other: Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462994

Contacts
Contact: Nikolas von Bubnoff, PD Dr. +49-89-4140 ext 5835 n.bubnoff@lrz.tum.de

Locations
Germany
Klinikum rechts der Isar - III. Medizinische Klinik und Poliklinik Recruiting
Munic, Bavaria, Germany, 81675
Contact: Nikolas von Bubnoff, PD Dr.    +49-89-4140 ext 5835    n.bubnoff@lrz.tum.de   
Principal Investigator: Nikolas von Bubnoff, PD Dr.         
Sponsors and Collaborators
Technische Universität München
Investigators
Study Chair: Nikolas von Bubnoff, PD Dr. Klinikum rechts der Isar
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01462994     History of Changes
Other Study ID Numbers: CSTI571BDE78T
Study First Received: October 25, 2011
Last Updated: December 10, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
Patients with GIST treated with standard therapy harboring activating mutations of CKIT and PDGFRA

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 23, 2014