NCT00749255

Brief Summary

The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

First QC Date

September 5, 2008

Last Update Submit

January 17, 2011

Conditions

Breast Cancer

Keywords

Breast CancerDigital archiver software

Study Arms (1)

FFDM

a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Known breast cancer patients

You may qualify if:

  • subjects with known breast cancer ages 18 and over
  • case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
  • source documents or mammographic interpretation must be available

You may not qualify if:

  • or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Imaging @ WellSpan Health

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Misty Hicks, RTRM

    Women's Imaging @ WellSpan Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

May 1, 2008

Study Completion

January 1, 2011

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

US(1)