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Personalised Program for Women Treated for Hodgkin Disease (PROPER)

Primary Purpose

Hodgkin Disease, Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intensive screening
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hodgkin Disease focused on measuring Hodgkin disease, Breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • François EISINGER, PhD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intensive screening

Arm Description

annual breast cancer detection based on mammography, echography and RMI.

Outcomes

Primary Outcome Measures

efficacy of the screening
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
The rate of interest is the % of women at high risk who will accept the intensive screening
adhesion
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
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
The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.

Full Information

First Posted
August 24, 2010
Last Updated
October 13, 2016
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT01188915
Brief Title
Personalised Program for Women Treated for Hodgkin Disease
Acronym
PROPER
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease, Breast Cancer
Keywords
Hodgkin disease, Breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intensive screening
Arm Type
Experimental
Arm Description
annual breast cancer detection based on mammography, echography and RMI.
Intervention Type
Procedure
Intervention Name(s)
intensive screening
Intervention Description
Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.
Primary Outcome Measure Information:
Title
efficacy of the screening
Description
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.
Time Frame
15 years
Secondary Outcome Measure Information:
Title
interest
Description
The rate of interest is the % of women at high risk who will accept the intensive screening
Time Frame
1 month
Title
adhesion
Description
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
Time Frame
1 month
Title
compliance
Description
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.
Time Frame
15 years
Title
psychologic impact
Description
The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.
Time Frame
15 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François EISINGER, PhD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
François EISINGER, PhD
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr/
Description
institut Paoli-Calmettes web site

Learn more about this trial

Personalised Program for Women Treated for Hodgkin Disease

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