National Breast Cancer and Lymphedema Registry

Breast Cancer Clinical Trial

Official title:

National Breast Cancer and Lymphedema Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01580800
• Other study ID #: SU-10042011-8529
• Secondary ID: 22349
• Status: Terminated
• Start date: September 12, 2011
• Est. completion date: March 2, 2018

Study information

• Verified date: June 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 549
• Est. completion date: March 2, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer survivorship

Exclusion Criteria:

• Age < 18 years old

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Rockson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preemptive diagnostic and treatment strategies	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

External Links

•   Stanford Healthcare Lymphedema Clinic