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BRAF V600E Mutations In Papillary Thyroid Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01417442
Recruitment Status : Unknown
Verified August 2011 by Bezmialem Vakif University.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : August 16, 2011
Information provided by:
Bezmialem Vakif University

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
Papillary Thyroid Carcinoma 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

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.
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 Measures :
  1. BRAF V600E MUTATION [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01417442

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Yeliz Emine Ersoy Recruiting
Istanbul, Turkey, 34308
Contact: Yeliz E Ersoy, DR    +905326102713   
Principal Investigator: Yeliz E Ersoy, M.D.         
Sponsors and Collaborators
Bezmialem Vakif University
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Responsible Party: Yeliz E. Ersoy, BEZMIALEM VAKIF UNIVERSITY Identifier: NCT01417442    
Other Study ID Numbers: 2011/5
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011
Keywords provided by Bezmialem Vakif University:
papillary thyroid carcinoma
poor prognosis
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adenocarcinoma, Papillary