Personalised Program for Women Treated for Hodgkin Disease

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01188915
• Other study ID #: PROPER/IPC 2010-001
• Status: Terminated
• Phase: N/A
• First received: August 24, 2010
• Last updated: October 13, 2016
• Start date: July 2010
• Est. completion date: July 2026

Study information

• Verified date: August 2016
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: July 2026
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Hodgkin Disease

Intervention

Procedure:
• intensive screening
Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.

Locations

Country	Name	City	State
France	François EISINGER, PhD	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 years	No
Secondary	interest	The rate of interest is the % of women at high risk who will accept the intensive screening	1 month	No
Secondary	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	1 month	No
Secondary	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.	15 years	No
Secondary	psychologic impact	The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.	15 years	No

External Links

•   institut Paoli-Calmettes web site