NCT01341171

Brief Summary

Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 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

Study Start

First participant enrolled

August 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
7.4 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

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

9.2 years

First QC Date

July 7, 2010

Last Update Submit

September 15, 2020

Conditions

Breast Cancer

Keywords

tamoxifenaromatase inhibitorsbreast cancerplatelets

Outcome Measures

Primary Outcomes (1)

  • Angiogenic Protein levels

    following 6 months of therapy

Study Arms (1)

tamoxifen or aromatase inhibitors

Eligibility Criteria

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

Women using tamoxifen or aromatase inhibitor therapy for greater than 6 months

You may qualify if:

  • women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist

You may not qualify if:

  • Use of heparin, warfarin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma, platelet activated samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chris E Holmes, MD, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 7, 2010

First Posted

April 25, 2011

Study Start

August 1, 2009

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations

US(1)