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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

August 24, 2010
March 19, 2013
July 2010
July 2028   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01188915 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Personalised Program for Women Treated for Hodgkin Disease
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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hodgkin Disease
  • Breast Cancer
Procedure: intensive screening
Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.
Experimental: intensive screening
annual breast cancer detection based on mammography, echography and RMI.
Intervention: Procedure: intensive screening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
145
Not Provided
July 2028   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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
France
 
NCT01188915
PROPER/IPC 2010-001
No
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: François EISINGER, PhD Institut Paoli-Calmettes
Institut Paoli-Calmettes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP