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Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers (ECO-THYR)

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ClinicalTrials.gov Identifier: NCT03787121
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.


Condition or disease Intervention/treatment
Thyroid Cancer Procedure: care management pathways

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Study Type : Observational
Estimated Enrollment : 423 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: care management pathways
    different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up


Primary Outcome Measures :
  1. cost related to the different management pathways of TC patient [ Time Frame: 24 months ]
    estimate the cost related to the different management pathways of TC patient during a lifetime period using a multi-state Markov model



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787121


Contacts
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Contact: Nadège Costa, PhD 0561778372 costa.n@chu-toulouse.fr

Locations
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France
University HospitalToulouse Recruiting
Toulouse, France
Contact: Nadège Costa, PhD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nadège Costa, PhD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03787121     History of Changes
Other Study ID Numbers: RC31/17/0378
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
health economics
care management pathways
overtreatment

Additional relevant MeSH terms:
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Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms