Feasibility of Breast Cancer Risk Evaluation in Women Fro... | NCT02997384

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

NCT02997384

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Dec 20, 2016Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Breastcancer

Interventions

Information

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2016/2422	Other Identifier	CSET number

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Dec 13, 2016

First Submission Date that Met QC Criteria

Dec 15, 2016

First Posted Date

Dec 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2016

Last Update Posted Date

Dec 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
General practitioner			Other: Information
gynecologist			Other: Information
radiologist			Other: Information

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Information	Other	information of women about their risk of breast cancer and the screening methods recommended for them	General practitioner gynecologist

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gustave Roussy		Villejuif	Val de Marne	94805	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided