Personalised Program for Women Treated for Hodgkin Disease (PROPER)

October 13, 2016 updated by: Institut Paoli-Calmettes

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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • François EISINGER, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: intensive screening
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

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: François EISINGER, PhD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 26, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

August 1, 2016

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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