NCT02514499

Brief Summary

The overall goal of the proposed research is to evaluate the uptake of testing and longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2 negative patients. This model will inform the selection of the outcomes and potential mediators and moderators of these outcomes, to inform the debate over utility, risks, and benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

4.3 years

First QC Date

July 31, 2015

Last Update Submit

July 23, 2019

Conditions

BRCA1/2 Negative

Keywords

patients

Outcome Measures

Primary Outcomes (1)

  • Completion of questionnaires

    2 years

Interventions

QuestionnairesOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Women and men (at least 18 YO) 2. English speaking AND 3. Negative for BRCA1 and BRCA2 mutations

You may not qualify if:

  • \. Non English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2015

First Posted

August 3, 2015

Study Start

July 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

US(1)