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CompletedNCT02561533Updated Oct 9, 2026

Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma

An interventional study of BRAF detection on fine needle aspiration biopsy (FNAB) in Papillary Thyroid Carcinoma, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by University of Aarhus · Not applicable, Interventional, and Diagnostic

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Papillary Thyroid Carcinoma
03

In context

Thyroid Cancer, Papillary

178 studies on the registry are indexed under Thyroid Cancer, Papillary; 54 are open to participants now.

This study's enrollment of 53 is close to the median of 51 across 110 interventional studies indexed under Thyroid Cancer, Papillary.

Browse Thyroid Cancer, Papillary studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Not undergoing thyroid surgery
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    BRAF immunohistochemistry (IHC)

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

Interventions

  • OtherBRAF detection on fine needle aspiration biopsy (FNAB)
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What researchers measure

Primary outcomes

  1. Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)

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

    Time frame: 1 day

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus C, 8000, Denmark
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT02561533
Responsible party
Kristine Zøylner Swan (MD PhD-student, University of Aarhus) — Principal investigator
First posted
Sep 28, 2015
Start date
Dec 2014
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Oct 9, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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