National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood

Early Detection of Cancer Clinical Trial

— DENACAPST  

Official title:

National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183401
• Other study ID #: C 16-03
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 20, 2017
• Start date: July 9, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: June 2017
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: charlotte demoor-goldschmidt, Dr
• Phone: +331 42 11 41 40
• Email: denacapst[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Detection of Cancer

Locations

Country	Name	City	State
France	Charlotte Demoor-Goldschmidt	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	follow of cancer screening recommendations	number of persons at risk found percentage of persons at risk contacted who answered percentage of persons contacted, who answered, who accepted the screening	2 years
Secondary	description of thyroid cancer screening	evaluation of the programme	2 years
Secondary	description of breast cancer screening	evaluation of the programme	2 years
Secondary	description of second cancers	analyze of the histological data	2 years
Secondary	psycho social analyze	evaluated by auto-questionaries :initial / final and comparison with persons who accepted to answer but who did not accept the screening	2 years