NCT02156362

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
643

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

11 years

First QC Date

May 29, 2012

Last Update Submit

January 26, 2021

Conditions

Thyroid Cancer

Keywords

Thyroid carcinomapredictive factorsrefractoryDifferentiatedfollicular origin

Outcome Measures

Primary Outcomes (1)

  • Rate of Thyroid cancer evolving to refractory stage

    5 years

Study Arms (1)

follow up

OTHER
Other: follow up visit

Interventions

follow up visitOTHER

At least 1 follow up visit per year will be done and an additional visit if needed.

follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon-Centre de Médecine Nucléaire Groupement Hospitalier Est 59 boulevard Pinel

Bron, 69677, France

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Claire BOURNAUD, MD

    Hospices Civils de Lyon- Centre de Médecine Nucléaire Groupement hospitalier est, 59 boulevard Pinel, 69677 Bron cedex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 5, 2014

Study Start

May 1, 2012

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

FR(1)