1,250
Participants
Start Date
April 30, 2016
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
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.
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.
Quality of Life Questionnaire
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.
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Memorial Sloan Kettering Westchester (Consent only), Harrison
RECRUITING
Memorial Sloan Kettering Nassau (Consent only), Uniondale
RECRUITING
Memorial Sloan Kettering Commack (Consent only), Commack
RECRUITING
Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge
RECRUITING
Memorial Sloan Kettering Monmouth (Consent only), Middletown
RECRUITING
Memorial Sloan Kettering Bergen (Consent only), Montvale
Memorial Sloan Kettering Cancer Center
OTHER