NCT01580800

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
549

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

6.5 years

First QC Date

April 13, 2012

Last Update Submit

June 27, 2018

Conditions

Breast CancerLymphedema

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer survivors

You may qualify if:

  • Breast cancer survivorship

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Stanley G Rockson

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Allan and Tina Neill Professor of Lymphatic Research and Medicine

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 19, 2012

Study Start

September 12, 2011

Primary Completion

March 2, 2018

Study Completion

March 2, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Locations

US(1)