NCT02561533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

2.6 years

First QC Date

September 17, 2015

Last Update Submit

July 13, 2017

Conditions

Papillary Thyroid Carcinoma

Outcome Measures

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

    1 day

Study Arms (1)

BRAF immunohistochemistry (IHC)

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

Interventions

BRAF detection on fine needle aspiration biopsy (FNAB)OTHER
BRAF immunohistochemistry (IHC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Not undergoing thyroid surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD-student

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 28, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

DK(1)