Back to resultsBRAF V600E Mutations In Papillary Thyroid Carcinoma
Primary Purpose
Papillary Thyroid Carcinoma
Status
Unknown status
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
BRAF V600E POSITIVITY
Sponsored by
About this trial
This is an interventional treatment trial for Papillary Thyroid Carcinoma focused on measuring papillary thyroid carcinoma, BRAF V600E, poor prognosis, aggressive
Eligibility Criteria
Inclusion Criteria:
- Patients with papillary thyroid cancer
Exclusion Criteria:
- Patients who do not want to be a part of this study
Sites / Locations
- Yeliz Emine ErsoyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BRAF V600E POSITIVITY
Arm Description
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.
Outcomes
Primary Outcome Measures
BRAF V600E MUTATION
Secondary Outcome Measures
Full Information
NCT ID
NCT01417442
First Posted
July 6, 2011
Last Updated
August 13, 2011
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT01417442
Brief Title
BRAF V600E Mutations In Papillary Thyroid Carcinoma
Official Title
Association Of Prognosis And BRAF V600E Mutations In Papillary Thyroid Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillary Thyroid Carcinoma
Keywords
papillary thyroid carcinoma, BRAF V600E, poor prognosis, aggressive
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BRAF V600E POSITIVITY
Arm Type
Experimental
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
BRAF V600E POSITIVITY
Intervention Description
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.
Primary Outcome Measure Information:
Title
BRAF V600E MUTATION
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with papillary thyroid cancer
Exclusion Criteria:
Patients who do not want to be a part of this study
Facility Information:
Facility Name
Yeliz Emine Ersoy
City
Istanbul
ZIP/Postal Code
34308
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeliz E Ersoy, DR
Phone
+905326102713
Email
yelizemineersoy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yeliz E Ersoy, M.D.
12. IPD Sharing Statement
Learn more about this trial
BRAF V600E Mutations In Papillary Thyroid Carcinoma
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