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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02997384
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 33.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breastcancer	Other: Information

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Feasibility of Breast Cancer Risk Evaluation in Women From the General Population
• Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation [up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 74 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy	Villejuif	Val de Marne	France	94805

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• ClinicalTrials.gov Identifier: NCT02997384
• Other Study ID Numbers: 2016-A01082-49; 2016/2422
• First Posted: Dec 20, 2016
• Last Update Posted: Dec 20, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 20, 2016