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TerminatedNCT01188915PROPERUpdated Oct 14, 2016

Personalised Program for Women Treated for Hodgkin Disease

An interventional study of intensive screening in Hodgkin Disease and Breast Cancer, sponsored by Institut Paoli-Calmettes. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Prevention

Why this study was terminated
Sponsor decision
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hodgkin Disease
  • Breast Cancer

Keywords

  • Hodgkin disease
  • Breast cancer
03

In context

Hodgkin Disease

914 studies on the registry are indexed under Hodgkin Disease; 136 are open to participants now.

This study's enrollment of 51 is above the median of 43 across 746 interventional studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women > 18 years
  • treated for Hodgkin disease
  • signed informed consent
  • high risk of breast cancer

Exclusion criteria

Exclusion Criteria:

  • patients unable to have a regular follow-up
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    intensive screening

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

    Procedure: intensive screening

Interventions

  • Procedureintensive screening

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 years

Secondary outcomes

  1. interest

    The rate of interest is the % of women at high risk who will accept the intensive screening

    Time frame: 1 month

  2. 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

    Time frame: 1 month

  3. 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.

    Time frame: 15 years

  4. psychologic impact

    The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.

    Time frame: 15 years

07

Study locations

1 site
  • François EISINGER, PhD
    Marseille, 13009, France
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01188915
Responsible party
Sponsor
First posted
Aug 26, 2010
Start date
Jul 2010
Primary completion
Sep 2016
Completion
Jul 2026 (estimated)
Last update
Oct 14, 2016

Study contacts

François EISINGER, PhD
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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