BRAF V600E Mutations In Papillary Thyroid Carcinoma

Papillary Thyroid Carcinoma Clinical Trial

Official title:

Association Of Prognosis And BRAF V600E Mutations In Papillary Thyroid Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417442
• Other study ID #: 2011/5
• Status: Recruiting
• Phase: Phase 0
• First received: July 6, 2011
• Last updated: August 13, 2011
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2011
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with papillary thyroid cancer

Exclusion Criteria:

• Patients who do not want to be a part of this study

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Papillary Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Turkey	Yeliz Emine Ersoy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BRAF V600E MUTATION		2 years	No