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Completed

NCT Number: NCT02561533

Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

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.

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Key information

Conditions

Papillary Thyroid Carcinoma Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus C, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRAF detection on fine needle aspiration biopsy (FNAB)

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2015
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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