National Breast Cancer and Lymphedema Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University
ClinicalTrials.gov Identifier:
NCT01580800
First received: April 13, 2012
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition
Breast Cancer
Lymphedema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Breast Cancer and Lymphedema Registry

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Preemptive diagnostic and treatment strategies [ Time Frame: Each enrolled patient will be followed for an average of 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer survivors

Criteria

Inclusion Criteria:

  • Breast cancer survivorship

Exclusion Criteria:

  • Age < 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580800

Contacts
Contact: Leslie Roche (650) 723-1396 lesroche@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanley Rockson
Investigators
Principal Investigator: Stanley G Rockson Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01580800     History of Changes
Other Study ID Numbers: SU-10042011-8529, 22349
Study First Received: April 13, 2012
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Breast Diseases
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014