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

June 20, 2017 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: charlotte demoor-goldschmidt, Dr
  • Phone Number: +331 42 11 41 40
  • Email: denacapst@inserm.fr

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
description of thyroid cancer screening
Time Frame: 2 years
evaluation of the programme
2 years
description of breast cancer screening
Time Frame: 2 years
evaluation of the programme
2 years
description of second cancers
Time Frame: 2 years
analyze of the histological data
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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