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

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ClinicalTrials.gov Identifier: NCT04274829
Recruitment Status : Completed
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Fabio Medas, University of Cagliari

Brief 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.

Condition or disease Intervention/treatment
Thyroid Cancer Lymph Node Metastases Procedure: Thyroidecomt and lymphectomy

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid
Actual Study Start Date : January 2010
Actual Primary Completion Date : January 2018
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
PTMC
Patients with papillary microcarcinoma of the thyroid
Procedure: Thyroidecomt and lymphectomy
Patients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy




Primary Outcome Measures :
  1. Incidence of lymph node metastasis [ Time Frame: 1 year ]
    To define the incidence of lymph node metastasis in patients with papillary microcarcinoma


Secondary Outcome Measures :
  1. Predicrive factors of lymph node metastasis [ Time Frame: 1 year ]
    To assesss predictive factors of lymph node metastasis



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
Sampling Method:   Non-Probability Sample
Study Population
Patients with papillary thyroid carcinoma
Criteria

Inclusion Criteria:

Patients with papillary microcarcinoma of the thyroid

Exclusion Criteria:

Patients with thyroid nodules > 1 cm; incomplete data


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 ClinicalTrials.gov identifier (NCT number): NCT04274829


Locations
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Italy
AOU Cagliari
Cagliari, CA, Italy, 09100
Sponsors and Collaborators
University of Cagliari
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabio Medas, Assistant Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT04274829    
Other Study ID Numbers: MICRO-PTC-LN
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Thyroid Neoplasms
Thyroid Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms