NCT04274829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

8 years

First QC Date

February 15, 2020

Last Update Submit

February 15, 2020

Conditions

Thyroid CancerLymph Node Metastases

Outcome Measures

Primary Outcomes (1)

  • Incidence of lymph node metastasis

    To define the incidence of lymph node metastasis in patients with papillary microcarcinoma

    1 year

Secondary Outcomes (1)

  • Predicrive factors of lymph node metastasis

    1 year

Study Arms (1)

PTMC

Patients with papillary microcarcinoma of the thyroid

Procedure: Thyroidecomt and lymphectomy

Interventions

Thyroidecomt and lymphectomyPROCEDURE

Patients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy

PTMC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with papillary thyroid carcinoma

You may qualify if:

  • Patients with papillary microcarcinoma of the thyroid

You may not qualify if:

  • Patients with thyroid nodules \> 1 cm; incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Cagliari

Cagliari, CA, 09100, Italy

Location

Related Publications (1)

  • Medas F, Canu GL, Cappellacci F, Boi F, Lai ML, Erdas E, Calo PG. Predictive Factors of Lymph Node Metastasis in Patients With Papillary Microcarcinoma of the Thyroid: Retrospective Analysis on 293 Cases. Front Endocrinol (Lausanne). 2020 Aug 25;11:551. doi: 10.3389/fendo.2020.00551. eCollection 2020.

    PMID: 32982963DERIVED

MeSH Terms

Conditions

Thyroid NeoplasmsLymphatic Metastasis

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 15, 2020

First Posted

February 18, 2020

Study Start

January 1, 2010

Primary Completion

January 1, 2018

Study Completion

February 1, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

IT(1)