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Trial record 1 of 1 for:    NCT02156362
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Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

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ClinicalTrials.gov Identifier: NCT02156362
Recruitment Status : Active, not recruiting
First Posted : June 5, 2014
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE May 29, 2012
First Posted Date  ICMJE June 5, 2014
Last Update Posted Date January 29, 2021
Actual Study Start Date  ICMJE May 2012
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Rate of Thyroid cancer evolving to refractory stage [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)
Official Title  ICMJE Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Thyroid Cancer
Intervention  ICMJE Other: follow up visit
At least 1 follow up visit per year will be done and an additional visit if needed.
Study Arms  ICMJE follow up
Intervention: Other: follow up visit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
643
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2014)
500
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02156362
Other Study ID Numbers  ICMJE 2011.665
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire BOURNAUD, MD Hospices Civils de Lyon- Centre de Médecine Nucléaire Groupement hospitalier est, 59 boulevard Pinel, 69677 Bron cedex
PRS Account Hospices Civils de Lyon
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP