Clinical Trial: APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.

Brief Summary: To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System)

Detailed Summary:

Aim of the study To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).

Design: Retrospective observational study. Scope: The study will be peformed at the Pathology Service, from cytological samples and paraffin file post-diagnosis. Mutations are detected by pyrosequencing technique.

Subject of study:

Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí.

Methodology:

  • Identification of cases
  • Detection of BRAF V600E mutation, initially in histological material from the surgical specimen, and if present, detection in cytological material.

The statistical analysis will use SPSS. Univariate and bivariate analysis will be done. Results will be presented in the form of frequency tables and percentages for qualitative variables and by average, median and standard deviation for quantitative variables. Pearson chi-square or Fisher's exact test will be applied. The Student t test or the Mann-Whitney test will be performed for quantitative variables.


Sponsor: Corporacion Parc Tauli

Current Primary Outcome: Improvement in diagnosis [ Time Frame: 6 months ]

To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Corporacion Parc Tauli

Dates:
Date Received: December 18, 2014
Date Started: February 2015
Date Completion:
Last Updated: September 21, 2016
Last Verified: September 2016