Personalised Program for Women Treated for Hodgkin Disease (PROPER)
|ClinicalTrials.gov Identifier: NCT01188915|
Recruitment Status : Terminated (Sponsor decision)
First Posted : August 26, 2010
Last Update Posted : October 14, 2016
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 or disease||Intervention/treatment||Phase|
|Hodgkin Disease Breast Cancer||Procedure: intensive screening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||July 2026|
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.
- efficacy of the screening [ Time Frame: 15 years ]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 ]The rate of interest is the % of women at high risk who will accept the intensive screening
- adhesion [ Time Frame: 1 month ]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 ]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 ]The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188915
|François EISINGER, PhD|
|Marseille, France, 13009|
|Principal Investigator:||François EISINGER, PhD||Institut Paoli-Calmettes|