Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

January 26, 2021 updated by: Hospices Civils de Lyon

It is generally estimated that 5 % of patients with thyroid cancer will develop distant metastases, and most of them had an advanced stage of the disease at presentation. Thirty per cent of them are resistant to radio iodine therapy and are called "refractory". Their long term survival is estimated to be less than 10 %.

The objective of this study is to identify the factors associated with poor outcome in a cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and medullary thyroid carcinomas were excluded.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

643

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron cedex, France, 69677
        • Hospices Civils de Lyon-Centre de Médecine Nucléaire Groupement Hospitalier Est 59 boulevard Pinel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Man or woman ≥ 18 years.
  • Thyroid cancer differentiated from follicular origins (papillary, vesicular or poorly differentiated carcinoma).
  • TNM classification: stage pT3 (≥2 cm), or pT4 or M1 at diagnosis.
  • Patient after post operative radioiodine therapy.

Exclusion Criteria:

  • Patient who can not be followed during the protocol.
  • Patient who does not consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: follow up
Other: follow up visit
At least 1 follow up visit per year will be done and an additional visit if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Thyroid cancer evolving to refractory stage
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Claire BOURNAUD, MD, Hospices Civils de Lyon- Centre de Médecine Nucléaire Groupement hospitalier est, 59 boulevard Pinel, 69677 Bron cedex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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