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Personalised Program for Women Treated for Hodgkin Disease (PROPER)

This study is currently recruiting participants.
Verified March 2013 by Institut Paoli-Calmettes
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01188915
First received: August 24, 2010
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death.

The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.


Condition Intervention
Hodgkin Disease
Breast Cancer
 Procedure: intensive screening

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Personalised Program for Women Treated for Hodgkin Disease : Risk Evaluation of Breast Cancer and Intensive Screening Program for Women at High Risk of Breast Cancer. PROPER/IPC 2010-001

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • efficacy of the screening [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    The efficacy of the screening will be evaluated by the rate of early stage breast cancer detected. The rate of in situ, < 10 mm(T1b), and N0 will be estimated.


Secondary Outcome Measures:
  • interest [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The rate of interest is the % of women at high risk who will accept the intensive screening

  • adhesion [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The adhesion rate is the % of women who will effectively undergo the first screnning among the women who had accepted their participation in this intensive screening

  • compliance [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    The compliance will be evaluated yearly. The number of exam realised compared to the theoric number and the time between 2 exams will be estimated.

  • psychologic impact [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.


Estimated Enrollment: 145
Study Start Date: July 2010
Estimated Primary Completion Date: July 2028 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intensive screening
annual breast cancer detection based on mammography, echography and RMI.
 Procedure: intensive screening
Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women > 18 years
  • treated for Hodgkin disease
  • signed informed consent
  • high risk of breast cancer

Exclusion Criteria:

  • patients unable to have a regular follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188915

Contacts
Contact: Dominique GENRE, MD (33) 4 91 22 37 78 bec@marseille.fnclcc.fr
Contact: Agnès BOYER CHAMMARD, MD (33) 4 91 22 37 78 bec@marseille.fnclcc.fr

Locations
France
François EISINGER, PhD Recruiting
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: François EISINGER, PhD Institut Paoli-Calmettes
  More Information

Additional Information:
institut Paoli-Calmettes web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01188915     History of Changes
Other Study ID Numbers: PROPER/IPC 2010-001
Study First Received: August 24, 2010
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
Hodgkin disease
Breast cancer

Additional relevant MeSH terms:
Hodgkin Disease
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013