Clinical trial NCT02743858: Lymphedema Surveillance Study
Official title: A Prospective Surveillance Program for Assessment and Treatment of Breast Cancer-Related Lymphedema After Axillary Lymph Node Dissection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lymphedema
Keywords: Lymphedema
Surveillance Program
Axillary Lymph Node Dissection
16-220
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK clinics

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Female breast cancer patients over the age of 18
* Patients consenting for unilateral axillary lymph node dissection (ALND) (prior history of sentinel lymph node biopsy allowed if \<6 months from consent)
* 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
* Initially consented patients, treated with SLNB alone, who were originally considered ineligible to continue on study, will be approached for re-enrollment
* 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)

Exclusion Criteria:

* Male breast cancer patients
* Patients consenting for bilateral axillary surgery
* Patients with prior history of surgical excision of one or more axillary lymph nodes or SLNB, performed \>6 months from date of consent
* Patients with prior history of ALND
* Patients with no breast surgery performed at MSK

Primary outcomes:
measure: number of incidences of lymphedema
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Barrio, MD
role: PRINCIPAL_INVESTIGATOR
References: