Clinical Trial: Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC

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 Summary:

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.


Sponsor: University of Aarhus

Current Primary Outcome: Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB) [ Time Frame: 1 day ]

Mutations status correlated to histological diagnoses and mutation status on histological samples


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Aarhus

Dates:
Date Received: September 17, 2015
Date Started: December 2014
Date Completion: September 2016
Last Updated: April 8, 2016
Last Verified: April 2016