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National Breast Cancer and Lymphedema Registry

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ClinicalTrials.gov Identifier: NCT01580800
Recruitment Status : Terminated (Low enrollment, incomplete participant data, and follow-up information)
First Posted : April 19, 2012
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Stanley Rockson, Stanford University

Study Description
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Brief 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.

Condition or disease
Breast Cancer Lymphedema

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 Design
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Study Type : Observational
Actual Enrollment : 549 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Breast Cancer and Lymphedema Registry
Actual Study Start Date : September 12, 2011
Actual Primary Completion Date : March 2, 2018
Actual Study Completion Date : March 2, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580800


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

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Responsible Party: Stanley Rockson, Allan and Tina Neill Professor of Lymphatic Research and Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01580800    
Other Study ID Numbers: SU-10042011-8529
22349 ( Other Identifier: Stanford University )
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases