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

• Sponsor: University of Cagliari (Other)
• Overall Status: Completed
• CT.gov ID: NCT04274829
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Actual Duration (Months): 121
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	Phase
Thyroid Cancer; Lymph Node Metastases	Procedure: Thyroidecomt and lymphectomy

Study Design

• 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: Jan 1, 2010
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incidence of lymph node metastasis [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 [1 year]

   To assesss predictive factors of lymph node metastasis

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients with papillary microcarcinoma of the thyroid

Exclusion Criteria:

Patients with thyroid nodules > 1 cm; incomplete data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Cagliari	Cagliari	CA	Italy	09100

Sponsors and Collaborators

• University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fabio Medas, Assistant Professor, University of Cagliari
• ClinicalTrials.gov Identifier: NCT04274829
• Other Study ID Numbers: MICRO-PTC-LN
• First Posted: Feb 18, 2020
• Last Update Posted: Feb 18, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Thyroid Neoplasms; Lymphatic Metastasis; Thyroid Diseases

Study Results

No Results Posted as of Feb 18, 2020