RECRUITING

Lymphedema Surveillance Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.

Official Title

A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection

Quick Facts

Study Start:2016-04
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02743858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female breast cancer patients over the age of 18
  2. * Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)
  3. * Patients consenting for unilateral sentinel lymph node biopsy (SLNB) and possible ALND are eligible for initial entry into the study, but will become ineligible if ALND is not performed
  4. * Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
  5. * Patients who self-identify as Black or White consenting for unilateral ALND or possible ALND will be approached for enrollment onto translational study (Cohort 3)
  1. * Male breast cancer patients
  2. * Patients consenting for bilateral axillary surgery
  3. * Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \>6 months from date of consent
  4. * Patients with prior history of ALND
  5. * Patients with no breast surgery performed at MSK

Contacts and Locations

Study Contact

Andrea Barrio, MD
CONTACT
646-888-5117
Babak Mehrara, MD
CONTACT
212-639-8639

Principal Investigator

Andrea Barrio, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Andrea Barrio, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04
Study Completion Date2025-04

Study Record Updates

Study Start Date2016-04
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Lymphedema
  • Surveillance Program
  • Axillary Lymph Node Dissection
  • 16-220

Additional Relevant MeSH Terms

  • Breast Cancer
  • Lymphedema