Personalised Program for Women Treated for Hodgkin Disease (PROPER)
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.
|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|
- 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.
- 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.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2026|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188915
|François EISINGER, PhD|
|Marseille, France, 13009|
|Principal Investigator:||François EISINGER, PhD||Institut Paoli-Calmettes|