Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

National Breast Cancer and Lymphedema Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 13, 2012
First Posted Date April 19, 2012
Last Update Posted Date June 29, 2018
Actual Study Start Date September 12, 2011
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Breast Cancer and Lymphedema Registry
Official Title National Breast Cancer and Lymphedema Registry
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Breast cancer survivors
Condition
  • Breast Cancer
  • Lymphedema
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 27, 2018)
549
Original Estimated Enrollment
 (submitted: April 17, 2012)
1000
Actual Study Completion Date March 2, 2018
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Breast cancer survivorship

Exclusion Criteria:

  • Age < 18 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01580800
Other Study ID Numbers SU-10042011-8529
22349 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Stanley Rockson, Stanford University
Study Sponsor Stanley Rockson
Collaborators Not Provided
Investigators
Principal Investigator: Stanley G Rockson Stanford University
PRS Account Stanford University
Verification Date June 2018