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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Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years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
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 25, 2011
Last Updated
March 16, 2016
Sponsor
Technical University of Munich
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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)

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