Increase Surveillance for Breast and Ovarian Cancers, Als... | NCT03319290

Studies
Increase Surveillance for Breast and Ovarian Cancers, Also to Determine Targeted Risk-reducing and Preventative Strategies

NCT03319290

Sponsor

Data Collection Analysis Business Management

Status

Unknown status

Last Update Posted

Jan 23, 2019Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Hereditary Cancer

Interventions

BRCA1 and BRCA2

Countries

United States

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

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2017Actual

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Oct 17, 2020Estimated

First Submitted Date

Oct 17, 2017

First Submission Date that Met QC Criteria

Oct 19, 2017

First Posted Date

Oct 24, 2017Actual

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

Jan 22, 2019

Last Update Posted Date

Jan 23, 2019Actual

Name	Class
PAS Research Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Observational study is to increase surveillance for breast and ovarian cancers, also to determine targeted risk-reducing and preventative strategies.

Detailed Description

The general design of this study is collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on BRCA testing and changes made to their specific SOP.

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

2,000Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BRCA1 and BRCA2	Genetic	Genetic breast and ovarian cancer testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Provider Structures and Processes	Plan of Care Changes due to BRCA testing. Provider based observational survey system on the health and well-being of patients and populations	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be a Medical Practitioner
- Medical Doctor (MD)
- Doctor of Osteopathic (DO)
- Physician Assistant (PA)
- Advanced Practice Registered Nurse (APRN)
- Nurse Practitioner (NP)
Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history

Exclusion Criteria:

Government-funded insurance data cannot be included in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Current standard operating procedures for providers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DCABM		Land O' Lakes	Florida	33558	United States

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