Mammographic Density and the Risk of Tumor Recurrence in Asian Women: a Case-control Study

May 11, 2016 updated by: National Taiwan University Hospital
To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcome in patients with invasive breast cancer after surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women diagnosed with invasive breast cancer who had undergone surgery between 2004 and 2009

Description

Inclusion Criteria:

  • Women diagnosed with invasive breast cancer between 2004 and 2009 who had undergone surgery and had the mammographic breast density ascertained before, or at, diagnosis.

Exclusion Criteria:

  • Women diagnosed with invasive breast cancer between 2004 and 2009 who had not undergone surgery or who had no mammographic breast density ascertained before, or at, diagnosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer women with known recurrences
Breast cancer women with known recurrences (locoregional recurrence and distant metastasis)
Other: Mammographic breast density at diagnosis
Mammographic breast density at diagnosis
Breast cancer women without recurrences
Other: Mammographic breast density at diagnosis
Mammographic breast density at diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hazard ratios for recurrence
Time Frame: 2004 to 2009
2004 to 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Hazard ratios for death
Time Frame: 2004 to 2009
2004 to 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jenny Ling-Yu Chen, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201401068RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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