- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188915
Personalised Program for Women Treated for Hodgkin Disease (PROPER)
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13009
- François EISINGER, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intensive screening
annual breast cancer detection based on mammography, echography and RMI.
|
Each year, women will have breast cancer detection based on mammography, echography and RMI.
Questionaries will also be completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
interest
Time Frame: 1 month
|
The rate of interest is the % of women at high risk who will accept the intensive screening
|
1 month
|
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
|
1 month
|
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.
|
15 years
|
psychologic impact
Time Frame: 15 years
|
The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.
|
15 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: François EISINGER, PhD, Institut Paoli-Calmettes
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROPER/IPC 2010-001
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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