National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood
NCT ID: NCT03183401
Last Updated: 2017-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2017-07-09
2019-10-31
Brief Summary
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With this programme, French centers organized themselves to provide to childhood cancer survivors adequate medical attention, which includes close medical surveillance for breast/thyroid cancer where appropriate, based on adequate risk stratification.
The aim of the study is to analyze if the recommendations about breast and thyroid cancer screening are followed in this population and secondly to provide more informations about these second cancers and about the screening.
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Detailed Description
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The inclusion of patients are validated by one team
Thyroid screening programme is based on US each 2 years Breast screening programme is based mainly on MRI each year
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* treated with radiotherapy
* health status compatible, and
* have had a long-term follow-up consultation describing a personalized post-cancer plan and,
* informed consent signed by patient
* being a woman and being 25 years or more for breast cancer screening, with a minimum delay of 8 years after radiotherapy, or
* with a significant irradiation dose to the breast (Irradiation that delivered at least 10 Gy on at least part of the breast (v 5\> 10 Gy) or on the mammary bud (v 100\> 10 Gy) - (centrally validated dose) or received TBI (Total Body Irradiation)\> 8 Gy according to a bi-fractioned scheme or\> 6 Gy in single dose)
* being a man or a woman and being 18 years or more for thyroid cancer screening with a minimum delay of 5 years after radiotherapy, and,
* with a significant irradiation dose to the thyroid (Irradiation having delivered at least 3 Gy on the thyroid (v100\> 3 Gy), or having received a TBI (Total Body Irradiation)\> 2 Gy, and / or treatment with 131i-metaiodobenzylguanidine), and
Exclusion Criteria
* patient in regular follow-up within the framework of a genetic susceptibility (ex li fraumeni)
* person placed under safeguard of justice
* patient treated with bilateral mastectomy, or
* patient being treated for breast cancer, or
* patient initially treated with radiotherapy for breast cancer
* Thyroidectomy, or
* patient undergoing treatment or with a personal history of thyroid cancer
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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charlotte demoor-goldschmidt
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
florent de vathaire
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
gerard michel
Role: STUDY_CHAIR
chu
pascal auquier
Role: STUDY_CHAIR
medical university of Marseille
Locations
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Charlotte Demoor-Goldschmidt
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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charlotte demoor-goldschmidt
Role: primary
florent de vathaire
Role: backup
Other Identifiers
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C 16-03
Identifier Type: -
Identifier Source: org_study_id
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