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

NCT ID: NCT02323724

Last Updated: 2016-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-07-31

Brief Summary

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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 Description

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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.

Conditions

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Papillary Thyroid Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Selected Papillary carcinoma

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.

BRAF V600E mutation by pyrosequencing technique

Intervention Type GENETIC

Interventions

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BRAF V600E mutation by pyrosequencing technique

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Non available cytological or histological material
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Rosa Bella Cueto

Coordinator of Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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2014/617

Identifier Type: -

Identifier Source: org_study_id

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