Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
- Conditions
- Papillary Thyroid Carcinoma
- Interventions
- Other: BRAF detection on fine needle aspiration biopsy (FNAB)
- Registration Number
- NCT02561533
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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)
- Not undergoing thyroid surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BRAF immunohistochemistry (IHC) BRAF detection on fine needle aspiration biopsy (FNAB) -
- Primary Outcome Measures
Name Time Method Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB) 1 day Mutations status correlated to histological diagnoses and mutation status on histological samples
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus C, Denmark