National Breast Cancer and Lymphedema Registry

June 27, 2018 updated by: Stanley Rockson
The purpose of the National Breast Cancer Lymphedema Registry is to collect health information in order to study the lymphedema as a complication of breast cancer treatment. The investigators hope to learn whether early diagnosis will help to prevent lymphedema or, if it does occur, to reduce the severity.

Study Overview

Status

Terminated

Conditions

Detailed Description

Historically, breast cancer-associated lymphedema has been relatively ignored, with mis-diagnosis, late diagnosis, and failure to treat. The condition has a measurable, substantial impact on patient function and perceived quality of life (QOL). Recent pilot studies suggest that interventions that are designed to facilitate early diagnosis and preventive strategies have a major impact on the incidence and severity of disease burden. This registry is designed to prospectively capture the relevant data to document the impact of preemptive diagnostic and treatment strategies.

Study Type

Observational

Enrollment (Actual)

549

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast cancer survivors

Description

Inclusion Criteria:

  • Breast cancer survivorship

Exclusion Criteria:

  • Age < 18 years old

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
Breast cancer survivors
Patients who have undergone breast cancer treatment (e.g. surgery, node dissection, chemotherapy and/or radiation therapy), and what affect this has had on their arm health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preemptive diagnostic and treatment strategies
Time Frame: Each enrolled patient will be followed for an average of 1 year
The methods for lymphedema surveillance and detection will be correlated to the new appearance of lymphedema in this cohort of breast cancer survivors. We will also assess severity of lymphedema and responsiveness to treatment strategies.
Each enrolled patient will be followed for an average of 1 year

Collaborators and Investigators

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

Sponsor

Stanley Rockson

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.

Helpful Links

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 (Actual)

September 12, 2011

Primary Completion (Actual)

March 2, 2018

Study Completion (Actual)

March 2, 2018

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 17, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-10042011-8529
  • 22349 (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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