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

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ClinicalTrials.gov Identifier: NCT03183401
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.


Condition or disease
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
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood
Estimated Study Start Date : July 9, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases




Primary Outcome Measures :
  1. follow of cancer screening recommendations [ Time Frame: 2 years ]
    number of persons at risk found percentage of persons at risk contacted who answered percentage of persons contacted, who answered, who accepted the screening


Secondary Outcome Measures :
  1. description of thyroid cancer screening [ Time Frame: 2 years ]
    evaluation of the programme

  2. description of breast cancer screening [ Time Frame: 2 years ]
    evaluation of the programme

  3. description of second cancers [ Time Frame: 2 years ]
    analyze of the histological data

  4. psycho social analyze [ Time Frame: 2 years ]
    evaluated by auto-questionaries :initial / final and comparison with persons who accepted to answer but who did not accept the screening



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183401


Contacts
Contact: charlotte demoor-goldschmidt, Dr +331 42 11 41 40 denacapst@inserm.fr

Locations
France
Charlotte Demoor-Goldschmidt Recruiting
Villejuif, France
Contact: charlotte demoor-goldschmidt         
Contact: florent de vathaire         
Sponsors and Collaborators
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

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03183401     History of Changes
Other Study ID Numbers: C 16-03
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
childhood cancer survivor