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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03623516
Other study ID # 2017Ao001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 1975
Est. completion date December 1, 2014

Study information

Verified date July 2018
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.


Description:

Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - We included all subjects living in the Marne or Ardennes Departments of France and who were diagnosed with papillary thyroid cancer between 1975 and 2014. We recorded socio-demographic variables, i.e. age at diagnosis and sex. Cancer characteristics were also recorded, namely year of diagnosis, International Classification of Diseases (ICD) 10th revision code associated with the papillary cancer, and the pTNM 2002 status. Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.


Recruitment information / eligibility

Status Completed
Enrollment 2008
Est. completion date December 1, 2014
Est. primary completion date December 1, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- clinical doagnosis of papillary thyroid cancer

- living in the Marne or Ardennes departments of France

Exclusion Criteria:

- cancer stage not determined

Study Design


Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Saint-Martin C, Dramé M, Dabakuyo S, Kanagaratnam L, Arveux P, Schvartz C. Overdiagnosis of thyroid cancer in the Marne and Ardennes Departments of France from 1975 to 2014. Ann Endocrinol (Paris). 2017 Feb;78(1):27-32. doi: 10.1016/j.ando.2016.07.005. Epub 2016 Sep 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overdiagnosis of thyroid cancer Overdiagnosis of thyroid cancer (defined as the diagnosis of disease that would otherwise not go on to cause symptoms or death, and was calculated by comparing the incidence rate of the localised cancer group and that of the invasive cancer group) 30 years
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