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Personalised Program for Women Treated for Hodgkin Disease

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01188915
Acronym
PROPER
Enrollment
51
Registered
2010-08-26
Start date
2010-07-31
Completion date
2026-07-31
Last updated
2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Hodgkin Disease

Keywords

Hodgkin disease, Breast cancer

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.

Interventions

PROCEDUREintensive screening

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

Sponsors

Institut Paoli-Calmettes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
efficacy of the screening15 yearsThe 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

MeasureTime frameDescription
interest1 monthThe rate of interest is the % of women at high risk who will accept the intensive screening
adhesion1 monthThe 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
compliance15 yearsThe 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 impact15 yearsThe psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026