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NCT04274829 Clinical Trial

Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid

Thyroid Cancer Clinical Trial

Official title:
Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04274829
Other study ID # MICRO-PTC-LN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date February 2020

Study information
Verified date February 2020
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Papillary thyroid microcarcinoma (PTMC), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. Nevertheless, the incidence of lymph node metastasis in PTMC is not negligible, reaching up to 65% in some series. The aim of this study was to assess the incidence of lymph node metastasis in patients with PTMC and to evaluate predictive factors for lymph node metastasis.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date February 2020
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients with papillary microcarcinoma of the thyroid

Exclusion Criteria:

Patients with thyroid nodules > 1 cm; incomplete data

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Thyroidecomt and lymphectomy
Patients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy

Locations
Country Name City State
Italy AOU Cagliari Cagliari CA

Sponsors (1)
Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of lymph node metastasis To define the incidence of lymph node metastasis in patients with papillary microcarcinoma 1 year
Secondary Predicrive factors of lymph node metastasis To assesss predictive factors of lymph node metastasis 1 year
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