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BRAF V600E Mutations In Papillary Thyroid Carcinoma

This study is currently recruiting participants.
Verified August 2011 by Bezmialem Vakif University
Sponsor:
Information provided by:
Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01417442
First received: July 6, 2011
Last updated: August 13, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.


Condition Intervention Phase
Papillary Thyroid Carcinoma
 Genetic: BRAF V600E POSITIVITY
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Association Of Prognosis And BRAF V600E Mutations In Papillary Thyroid Carcinoma

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • BRAF V600E MUTATION [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BRAF V600E POSITIVITY
This mutation will be analysed using the tumor tissues of the patients operated for thyroid diseases and diagnosed with papillary thyroid carcinoma. And mutation positive patients will be investigated for the aggressive characteristics of the tumor.
 Genetic: BRAF V600E POSITIVITY
BRAF V600E mutation analysis will be made using the tumor tissues of the patients with papillary thyroid cancer (3 sections of 7 mm from he paraffin blocks). And mutation positives and negatives will be identified.

Detailed Description:

Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy and BRAF V600E mutation is the most common genetic alteration identified in PTC, ranging from 25 to 80%, with the average rate about 45%. Various studies demonstrated a relationship between BRAF V600E mutation and aggressive characteristics of the cancer, including the worse patient prognosis. But,there are no studies from Turkey regarding this topic. So the investigators will examine BRAF V600E mutation in our patients with PTC and try to assess the role of this mutation in prognosis and further management of the patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with papillary thyroid cancer

Exclusion Criteria:

  • Patients who do not want to be a part of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417442

Locations
Turkey
Yeliz Emine Ersoy Recruiting
Istanbul, Turkey, 34308
Contact: Yeliz E Ersoy, DR     +905326102713     yelizemineersoy@yahoo.com    
Principal Investigator: Yeliz E Ersoy, M.D.            
Sponsors and Collaborators
Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Yeliz E. Ersoy, BEZMIALEM VAKIF UNIVERSITY
ClinicalTrials.gov Identifier: NCT01417442     History of Changes
Other Study ID Numbers: 2011/5
Study First Received: July 6, 2011
Last Updated: August 13, 2011
Health Authority: Turkey: Ethics Committee

Keywords provided by Bezmialem Vakif University:
papillary thyroid carcinoma
BRAF V600E
poor prognosis
aggressive

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013