Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)
Primary Purpose
Gastrointestinal Stromal Tumors
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Stromal Tumors focused on measuring Patients with GIST treated with standard therapy harboring activating mutations of CKIT and PDGFRA
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 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
Sites / Locations
- Klinikum rechts der Isar - III. Medizinische Klinik und Poliklinik
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Single arm
Arm Description
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01462994
First Posted
October 25, 2011
Last Updated
March 16, 2016
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01462994
Brief Title
Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Patients with GIST treated with standard therapy harboring activating mutations of CKIT and PDGFRA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolas von Bubnoff, PD Dr.
Organizational Affiliation
Klinikum rechts der Isar
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum rechts der Isar - III. Medizinische Klinik und Poliklinik
City
Munic
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)
We'll reach out to this number within 24 hrs