Feasibility of Breast Cancer Risk Evaluation in Women From the General Population (RIVIERA)

December 15, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

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
    • Val de Marne
      • Villejuif, Val de Marne, France, 94805
        • Gustave Roussy

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 to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women 40 to 74 years seen in consultation by their attending physician, gynecologist or radiologist

Description

Inclusion Criteria:

  • Woman from 40 to 74 years old
  • Understanding the French language

Exclusion Criteria:

Women will not be eligible for study if they are in any of the following situations:

  • Cancer active or in the course of treatment type surgery, chemotherapy, or radiotherapy, whether breast or other organ
  • Recent diagnosis <1 year of suspicious or cancerous lesions
  • Psychiatric pathology not compatible with the study
  • Poor understanding of the French language

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General practitioner
Other: Information
information of women about their risk of breast cancer and the screening methods recommended for them
gynecologist
Other: Information
information of women about their risk of breast cancer and the screening methods recommended for them
radiologist
Other: Information
information of women about their risk of breast cancer and the screening methods recommended for them

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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

December 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01082-49
  • 2016/2422 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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