Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

NCT ID: NCT02561533

Last Updated: 2017-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Papillary Thyroid Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BRAF immunohistochemistry (IHC)

Group Type EXPERIMENTAL

BRAF detection on fine needle aspiration biopsy (FNAB)

Intervention Type OTHER

Interventions

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BRAF detection on fine needle aspiration biopsy (FNAB)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Kristine Zøylner Rubeck

MD PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TIHCDBMTC1

Identifier Type: -

Identifier Source: org_study_id

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