Back to resultsDetermination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)
Primary Purpose
Thyroid Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
follow up visit
Sponsored by
About this trial
This is an interventional other trial for Thyroid Cancer focused on measuring Thyroid carcinoma, predictive factors, refractory, Differentiated, follicular origin
Eligibility Criteria
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.
Sites / Locations
- Hospices Civils de Lyon-Centre de Médecine Nucléaire Groupement Hospitalier Est 59 boulevard Pinel
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
follow up
Arm Description
Outcomes
Primary Outcome Measures
Rate of Thyroid cancer evolving to refractory stage
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156362
Brief Title
Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)
Official Title
Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
Thyroid carcinoma, predictive factors, refractory, Differentiated, follicular origin
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
643 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
follow up
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
follow up visit
Intervention Description
At least 1 follow up visit per year will be done and an additional visit if needed.
Primary Outcome Measure Information:
Title
Rate of Thyroid cancer evolving to refractory stage
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire BOURNAUD, MD
Organizational Affiliation
Hospices Civils de Lyon- Centre de Médecine Nucléaire Groupement hospitalier est, 59 boulevard Pinel, 69677 Bron cedex
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon-Centre de Médecine Nucléaire Groupement Hospitalier Est 59 boulevard Pinel
City
Bron cedex
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Learn more about this trial
Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)
We'll reach out to this number within 24 hrs