Clinical trial NCT03183401: National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood
Official title: National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Detection of Cancer
Keywords: childhood cancer survivor
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-06-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from FCCSS cohort / LEA cohort - or not involved in a cohort living in France treated for a malignant illness (cancer, leukemia) at the age of 20 or before ans still alive 5 years after

Brief summary: The DENACAPST programme represents an important initiative to provide near nation-wide roll-out of an important cancer surveillance program for childhood cancer survivors. The program is based on internationally recognized standards in cancer surveillance, which were developed by the International Guideline Harmonization Group (IGHG) with support of all relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and the United States and recognized French recommendations about breast screening for women at high risk of cancer.

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.

Detailed description: Every center which has patient at risk can participate. Main inclusion criteria : French childhood cancer survivor (5 years or more of delay with the treatment) - becoming adult - with a past history of radiotherapy at the age of 20 years or before, with a significant dose irradiation on the thyroid or the breast

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

Eligibility criteria: Inclusion Criteria:

* childhood cancer survivor, and
* 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

  + Inclusion criteria for breast screening
* 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)

  +Inclusion criteria for thyroid screening:
* 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:

* life expectancy \<10 years due to other pathology
* patient in regular follow-up within the framework of a genetic susceptibility (ex li fraumeni)
* person placed under safeguard of justice

  + exclusion criteria for breast cancer screening :
* patient treated with bilateral mastectomy, or
* patient being treated for breast cancer, or
* patient initially treated with radiotherapy for breast cancer

  + exclusion criteria for breast cancer screening :
* Thyroidectomy, or
* patient undergoing treatment or with a personal history of thyroid cancer

Primary outcomes:
measure: follow of cancer screening recommendations
timeFrame: 2 years
Secondary outcomes:
measure: description of thyroid cancer screening
timeFrame: 2 years
measure: description of breast cancer screening
timeFrame: 2 years
measure: description of second cancers
timeFrame: 2 years
measure: psycho social analyze
timeFrame: 2 years
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Charlotte Demoor-Goldschmidt
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: charlotte demoor-goldschmidt
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: florent de vathaire
role: PRINCIPAL_INVESTIGATOR
affiliation: chu
name: gerard michel
role: STUDY_CHAIR
affiliation: medical university of Marseille
name: pascal auquier
role: STUDY_CHAIR
References: