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

NCT03183401 | Unknown

• 1 other identifier: C 16-03
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Detection of Cancer

Keywords

childhood cancer survivor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• description of thyroid cancer screening

  2 years

• description of breast cancer screening

  2 years

• description of second cancers

  2 years

• psycho social analyze

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Charlotte Demoor-Goldschmidt

Villejuif, France

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• gerard michel

  chu

  STUDY CHAIR

• pascal auquier

  medical university of Marseille

  STUDY CHAIR

Central Study Contacts

charlotte demoor-goldschmidt, Dr

CONTACT

+331 42 11 41 40; denacapst@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: July 9, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)