NCT00383604

Brief Summary

To better understand the mechanisms leading to lymphedema development in breast cancer survivors, and the implications for potential innovative approaches to the screening, prevention and treatment of this condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

6.7 years

First QC Date

September 29, 2006

Last Update Submit

May 28, 2013

Conditions

LymphedemaBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • assess insulin sensitivity in late breast cancer survivors

    visit 2

Eligibility Criteria

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

Breast cancer survivors

You may qualify if:

  • Patients enrolled in the proposed studies must be survivors of breast cancer at a time point at least 4 years following the initial surgery and radiotherapy for the disease.
  • Patients must have a history of unilateral axillary lymph node dissection.
  • Patients referred to, or that receive their care within the Stanford University Breast Cancer Program and the Stanford Center for Lymphatic and Venous Disorders.
  • Patients will be required to have the capacity to provide informed consent.

You may not qualify if:

  • Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
  • Patients will not be enrolled if they are taking drugs that affect carbohydrate metabolism.
  • Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue 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

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 3, 2006

Study Start

July 1, 2005

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)