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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02156362

Collaborator

(none)

643

Enrollment

Location

Arm

132

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer	Other: follow up visit	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

643 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of Thyroid cancer evolving to refractory stage [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon-Centre de Médecine Nucléaire Groupement Hospitalier Est 59 boulevard Pinel	Bron cedex		France	69677

Sponsors and Collaborators

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