NCT02436772

Brief Summary

This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

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

First Submitted

Initial submission to the registry

May 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

May 13, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2017

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

May 4, 2015

Last Update Submit

September 1, 2020

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Concordance with standard test

    determined by the comparison between OncoCEE test and conventional test

    6 months

Eligibility Criteria

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

100 metastatic breast cancer patients from 1 clinic in Tennessee

You may qualify if:

  • Current patient at participating clinic
  • Metastatic breast cancer diagnosis
  • years of age or older

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Erika Hamilton, MD

    SCRI

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 7, 2015

Study Start

May 13, 2015

Primary Completion

July 7, 2017

Study Completion

July 7, 2017

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

US(1)