Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

University of Aarhus

Status: Completed

Conditions: Papillary Thyroid Carcinoma

Treatments: Other: BRAF detection on fine needle aspiration biopsy (FNAB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02561533

TIHCDBMTC1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

BRAF immunohistochemistry (IHC)

Experimental group

Treatment:

Other: BRAF detection on fine needle aspiration biopsy (FNAB)