Papillary Thyroid CancerOTCancerNCT03623516
Overdiagnosis of Thyroid Cancer in the Marne and Ardennes Departments of France From 1975 to 2014
An observational study of Papillary Thyroid Cancer, run by CHU de Reims at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Cancer
- How many people
- 2,008 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 1975to 1 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects living in the Marne or Ardennes Departments of France and who were diagnosed with papillary thyroid cancer between 1975 and 2014.
Who may be able to join
- clinical doagnosis of papillary thyroid cancer
- living in the Marne or Ardennes departments of France
Who cannot join
- cancer stage not determined
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Thyroid neoplasms; Thyroid gland; ;, Thyroid gland, Incidence, Overdiagnosis
- Medical subject headings
- Thyroid Cancer, Papillary, Thyroid Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid cancer | All subjects living in the Marne or Ardennes Departments of France and who were diagnosed with papillary thyroid cancer between 1975 and 2014. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jan 1975
- Primary completion1 Dec 2014
- Study completion1 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623516
- Sponsor's protocol ID
- 2017Ao001
- Acronym
- OTCancer
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saint-Martin C, Drame 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.
PubMed 27641079
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overdiagnosis of Thyroid Cancer in the Marne and Ardennes Departments of France From 1975 to 2014
- ClinicalTrials.gov ID
- NCT03623516
- Acronym / sponsor ID
- OTCancer / 2017Ao001
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Thyroid neoplasms; Thyroid gland; ;, Thyroid gland, Incidence, Overdiagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,008 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Jan 1975 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid cancer | – | –All subjects living in the Marne or Ardennes Departments of France and who were diagnosed with papillary thyroid cancer between 1975 and 2014. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects living in the Marne or Ardennes Departments of France and who were diagnosed with papillary thyroid cancer between 1975 and 2014.
Key inclusion criteria (2 listed)
- clinical doagnosis of papillary thyroid cancer
- living in the Marne or Ardennes departments of France
Key exclusion criteria (1 listed)
- cancer stage not determined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overdiagnosis of thyroid cancer
Time frame: 30 years
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 27641079Saint-Martin C, Drame 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Cancer, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overdiagnosis of thyroid cancer (time frame: 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623516, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.