NCT01188915

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

October 14, 2016

Status Verified

August 1, 2016

Enrollment Period

6.2 years

First QC Date

August 24, 2010

Last Update Submit

October 13, 2016

Conditions

Hodgkin DiseaseBreast Cancer

Keywords

Hodgkin diseaseBreast cancer

Outcome Measures

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.

    15 years

Secondary Outcomes (4)

  • interest

    1 month

  • adhesion

    1 month

  • compliance

    15 years

  • psychologic impact

    15 years

Study Arms (1)

intensive screening

EXPERIMENTAL

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

Procedure: intensive screening

Interventions

intensive screeningPROCEDURE

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

intensive screening

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients unable to have a regular follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

François EISINGER, PhD

Marseille, 13009, France

Location

Related Links

MeSH Terms

Conditions

Hodgkin DiseaseBreast Neoplasms

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • François EISINGER, PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 26, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2016

Study Completion (Estimated)

July 1, 2026

Last Updated

October 14, 2016

Record last verified: 2016-08

Locations

FR(1)