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NCT02997384 Clinical Trial

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

Breastcancer Clinical Trial

— RIVIERA  

Official title:
Feasibility of Breast Cancer Risk Evaluation in Women From the General Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02997384
Other study ID # 2016-A01082-49
Secondary ID 2016/2422
Status Active, not recruiting
Phase N/A
First received December 13, 2016
Last updated December 15, 2016
Start date December 2016
Est. completion date June 2018

Study information
Verified date December 2016
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date June 2018
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 74 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Information
information of women about their risk of breast cancer and the screening methods recommended for them

Locations
Country Name City State
France Gustave Roussy Villejuif Val de Marne

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation up to 1 year No
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