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Personalised Program for Women Treated for Hodgkin Disease (PROPER)

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT01188915
First received: August 24, 2010
Last updated: October 13, 2016
Last verified: August 2016
  Purpose

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 Intervention
Hodgkin Disease Breast Cancer Procedure: intensive screening

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 51
Study Start Date: July 2010
Estimated Study Completion Date: July 2026
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188915

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

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01188915     History of Changes
Other Study ID Numbers: PROPER/IPC 2010-001
Study First Received: August 24, 2010
Last Updated: October 13, 2016

Keywords provided by Institut Paoli-Calmettes:
Hodgkin disease
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Hodgkin Disease
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2017