search
Back to results

Determination 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
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 29, 2012
Last Updated
January 26, 2021
Sponsor
Hospices Civils de Lyon
search

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