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AzTrials

Early Detection of CancerDENACAPSTNCT03183401

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

An observational study of Early Detection of Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early Detection of Cancer
How many people
2,000 participants
Where
1 siteFrance
Study dates
9 Jul 2017to 31 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

charlotte demoor-goldschmidt, Dr contact

+331 42 11 41 40

denacapst@inserm.fr

France1 site, 1 recruiting

  • Charlotte Demoor-Goldschmidt

    Villejuif

    charlotte demoor-goldschmidt

    florent de vathaire

    Recruiting

Other trials in France

About this study

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.

Read the 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

Keywords
childhood cancer survivor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (4)

  1. description of thyroid cancer screening

    evaluation of the programme

    Measured: 2 years

  2. description of breast cancer screening

    evaluation of the programme

    Measured: 2 years

  3. description of second cancers

    analyze of the histological data

    Measured: 2 years

  4. psycho social analyze

    evaluated by auto-questionaries :initial / final and comparison with persons who accepted to answer but who did not accept the screening

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start9 Jul 2017 (estimated)
  3. Primary completion31 Oct 2019 (estimated)
  4. Study completion31 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183401
Sponsor's protocol ID
C 16-03
Acronym
DENACAPST
Status last verified
Jun 2017
First submitted
8 Jun 2017
Last updated
21 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Early Detection of Cancer, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact charlotte demoor-goldschmidt, Dr (+331 42 11 41 40, denacapst@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

follow of cancer screening recommendations (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03183401.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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