Back to resultsDetection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
Primary Purpose
Papillary Thyroid Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
BRAF detection on fine needle aspiration biopsy (FNAB)
Sponsored by
About this trial
This is an interventional diagnostic trial for Papillary Thyroid Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm)
- Undergoing thyroid surgery (histology of index nodule)
Exclusion Criteria:
- Not undergoing thyroid surgery
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BRAF immunohistochemistry (IHC)
Arm Description
Outcomes
Primary Outcome Measures
Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)
Mutations status correlated to histological diagnoses and mutation status on histological samples
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02561533
Brief Title
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
Official Title
Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.
Detailed Description
The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.
FNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BRAF immunohistochemistry (IHC)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
BRAF detection on fine needle aspiration biopsy (FNAB)
Primary Outcome Measure Information:
Title
Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)
Description
Mutations status correlated to histological diagnoses and mutation status on histological samples
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm)
Undergoing thyroid surgery (histology of index nodule)
Exclusion Criteria:
Not undergoing thyroid surgery
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
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