BRAF V600E Mutations In Papillary Thyroid Carcinoma

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01417442
Collaborator
(none)
150
1
1
12
12.5

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Genetic: BRAF V600E POSITIVITY
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Association Of Prognosis And BRAF V600E Mutations In Papillary Thyroid Carcinoma
Study Start Date :
Jul 1, 2011
Anticipated Primary Completion Date :
Jul 1, 2012
Anticipated Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. BRAF V600E MUTATION [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with papillary thyroid cancer
Exclusion Criteria:
  • Patients who do not want to be a part of this study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yeliz Emine Ersoy Istanbul Turkey 34308

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01417442
Other Study ID Numbers:
  • 2011/5
First Posted:
Aug 16, 2011
Last Update Posted:
Aug 16, 2011
Last Verified:
Aug 1, 2011

Study Results

No Results Posted as of Aug 16, 2011