NCT03787121

Brief Summary

The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs. The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model. This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

December 24, 2018

Last Update Submit

August 26, 2021

Conditions

Keywords

health economicscare management pathwaysovertreatment

Outcome Measures

Primary Outcomes (1)

  • cost related to the different management pathways of TC patient

    estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model

    24 months

Interventions

different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Evathyr database collected by the Oncomip network: Cohort describing the initial management of 423 patients with TC diagnosed in 2014 and passed in the process of Multidisciplinary Team Meeting (MTM).

You may qualify if:

  • all patients with a good prognosis of the TC
  • diagnosed in 2014
  • whose medical file discussed in MultiDisciplinary Team Meeting (MDTM) in Midi-Pyrenees

You may not qualify if:

  • patients whose surgical management was carried out outside Midi Pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University HospitalToulouse

Toulouse, France

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Nadège Costa, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2018

First Posted

December 26, 2018

Study Start

April 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 27, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations