Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis (TOMOSEIN)

March 21, 2018 updated by: Centre Oscar Lambret
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1069

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Oscar Lambret Center
      • Roubaix, France, 59100
        • Centre Hospitalier - Pavillon Paul Gelé
      • Valenciennes, France, 59300
        • Centre Hospitalier
      • Valenciennes, France, 59300
        • Clinique des dentellières

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
  • age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
  • breast size suitable for detector size
  • possible prior mastectomy
  • security social covered
  • signed informed consent

Exclusion Criteria:

  • breast implant
  • high genetic risk (mutation)
  • under justice measures
  • breast feeding or pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: breast cancer histologically proven
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
Device: tomosynthesis
2 incidences 3D numeric mammography
Device: 2D mammography
2 incidences 2D analogic mammography
Active Comparator: surveillance of a treated breast cancer
surveillance of patient already treated for breast cancer must have annual mammography
Device: tomosynthesis
2 incidences 3D numeric mammography
Device: 2D mammography
2 incidences 2D analogic mammography
Active Comparator: diagnosis of a detected anomaly
patient addressed for diagnosis of a detected anomaly
Device: tomosynthesis
2 incidences 3D numeric mammography
Device: 2D mammography
2 incidences 2D analogic mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the benefit of tomosynthesis for diagnosis
Time Frame: 30 months
number of avoided focused cliches and ultrasound, after tomosynthesis analysis
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine best incidence of realization
Time Frame: 30 months
face, medial side or oblique
30 months
measurement of breast irradiation
Time Frame: 30 months
comparison of tomosynthesis irradiation and focused cliches irradiation
30 months
evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
Time Frame: 30 months
30 months
number of additional cancer detected by tomosynthesis
Time Frame: 30 months
number of breast cancer detected through tomosynthesis
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Sophie TAIEB, MD, Oscar Lambret Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2012

Primary Completion (Actual)

March 16, 2017

Study Completion (Actual)

March 16, 2017

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 6, 2012

Study Record Updates

Last Update Posted (Actual)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOMOSEIN-1104
  • 2011-002051-34 (Other Identifier: IDRCB number (ANSM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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