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

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.

Study Overview

• Status: Unknown
• Conditions: Early Detection of Cancer

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

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• France
  • Villejuif, France
    • Recruiting
    • Charlotte Demoor-Goldschmidt
    • Contact: charlotte demoor-goldschmidt
    • Contact: florent de vathaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of thyroid cancer screening	evaluation of the programme	2 years
description of breast cancer screening	evaluation of the programme	2 years
description of second cancers	analyze of the histological data	2 years
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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: charlotte demoor-goldschmidt, Institut National de la Santé Et de la Recherche Médicale, France; Principal Investigator: florent de vathaire, Institut National de la Santé Et de la Recherche Médicale, France; Study Chair: gerard michel, CHU; Study Chair: pascal auquier, medical university of Marseille

Study record dates

Study Major Dates

• Study Start (Anticipated): July 9, 2017
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): October 31, 2019

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: childhood cancer survivor
• Other Study ID Numbers: C 16-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No