Lymphedema Surveillance Study

RecruitingOBSERVATIONAL
Enrollment

1,250

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2026

Conditions
Breast CancerLymphedema
Interventions
OTHER

Bilateral arm measurements

Pts treated with ALND, bilateral arm measurements will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder \& the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. Measurements will be performed before surgery, post-operatively \& at timepoints of 6,12,18, \& 24 months after surgery for 2 years will be obtained using the Perometer (Model 350 NT Perometer, Per-System) for bioimpedance measurements. Pts who have not yet developed lymphedema by 2 years, an additional measurement at approx 3 years post-surgery will be performed. If pt is diag with lymphedema at the 3-year visit, she will be asked to continue on study for an additional year. Pts treated with SLNB alone, following re-consent, a long-term follow-up volumetric arm measurement will be obtained using the perometer \& circumferential arm measurements at a minimum of 2 years post-surgery.

OTHER

Body mass index (BMI)

Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.

BEHAVIORAL

Quality of Life Questionnaire

OTHER

Blood draw

Patients enrolled in the translational study (Cohort 3) will undergo blood draws for serum collection preoperatively and 12-24 months postoperatively to test for FGF2, IL4, IL10, TGFB, Leptin, IL6, and CRP. At both timepoints, up to 20 mL of blood will be collected.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Consent only), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Consent only), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack (Consent only), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Consent only), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Consent only), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER