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Personalised Program for Women Treated for Hodgkin Disease (PROPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01188915
Recruitment Status : Terminated (Sponsor decision)
First Posted : August 26, 2010
Last Update Posted : October 14, 2016
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : July 2026

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. interest [ Time Frame: 1 month ]
    The rate of interest is the % of women at high risk who will accept the intensive screening

  2. 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

  3. 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.

  4. psychologic impact [ Time Frame: 15 years ]
    The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01188915

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François EISINGER, PhD
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
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Principal Investigator: François EISINGER, PhD Institut Paoli-Calmettes

Additional Information:
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Responsible Party: Institut Paoli-Calmettes Identifier: NCT01188915    
Other Study ID Numbers: PROPER/IPC 2010-001
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: August 2016
Keywords provided by Institut Paoli-Calmettes:
Hodgkin disease
Breast cancer
Additional relevant MeSH terms:
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Hodgkin Disease
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases