NCT02997384

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

December 13, 2016

Last Update Submit

December 15, 2016

Conditions

Breastcancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation

    up to 1 year

Study Arms (3)

General practitioner

Other: Information

gynecologist

Other: Information

radiologist

Other: Information

Interventions

InformationOTHER

information of women about their risk of breast cancer and the screening methods recommended for them

General practitionergynecologistradiologist

Eligibility Criteria

Age40 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 20, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)