Papillary Thyroid Carcinoma
Conditions
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.
Interventions
OTHERBRAF detection on fine needle aspiration biopsy (FNAB)
Sponsors
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed