Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

Papillary Thyroid Carcinoma Clinical Trial

Official title:

Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561533
• Other study ID #: TIHCDBMTC1
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: July 13, 2017
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)	Mutations status correlated to histological diagnoses and mutation status on histological samples	1 day