Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ

Completed

Conditions studied: Ductal Carcinoma In Situ

In brief

Patients with ductal carcinoma in situ (DCIS) treated with available therapies have experienced excellent outcomes and very low mortality rates due to the disease's non-invasive nature. However, considerable debate exists as to how the DCIS lesion should be treated. As a result, determining strategies to manage DCIS has been identified as a research priority. The role of sentinel lymph node biopsy (SLNB) for DCIS management is controversial in general and needs further scrutiny. Our study addresses this evidence gap as the investigators propose a retrospective cohort study to investigate the outcome of SLNB among DCIS patients. Specifically, the investigators will compare the outcomes, including survival outcomes and treatment side effects, among women older than 67 years of age with DCIS receiving SLNB vs. not receiving SLNB within 6 months of DCIS diagnosis. The investigators have two primary aims in this study: Aim 1: the investigators select our study sample using SEER-Medicare database. The investigators will determine associations between SLNB and acute/subacute side effects, including lymphedema, pain, and limitation of movement of upper extremity from the first breast conserving surgery to 9 months post-diagnosis. Aim 2: the investigators will determine associations between SLNB and long-term outcomes, including breast cancer specific mortality, ipsilateral invasive breast cancer diagnosis, subsequent mastectomy as treated recurrence, and lasting side effects, from \>9 months post-diagnosis to death or the end of this study period. Given the nature of our observational study design, the investigators will apply standard multivariate analyses and propensity score methodology to reduce the influence from confounders. The investigators will control for patient demographics, comorbidities, functional status, tumor characteristics, and prior healthcare utilization. Using distance to the nearest provider that uses SLNB for DCIS or surgeon's tendency in using SLNB for stage I/II breast cancer, the investigators also plan to conduct instrument variable analyses if necessary. Stratifying patients by key DCIS characteristics (including grade, comedonecrosis, and tumor size) and their predicted life expectancy (given their age and comorbidities), the investigators also hope to identify patient subgroups who may safely forgo SLNB. The study would provide evidence on the efficacy and safety outcome of SLNB for DCIS management.

Key facts

Study ID

NCT02908178

Run by

Yale University

People needed

28291

Starts

2017-01-25

Expected to finish

2018-06-29

Last updated by the study team

2019-05-15

Who can join

Age: 67 and older, up to 94. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female DCIS patients older than 67 years and younger than 94 years who were enrolled in a fee-for-service Medicare program and resided in the SEER areas.
• Aim 1: DCIS patients who received breast conserving surgery (BCS) as their first surgery
• Aim 1: DCIS patients who were diagnosed DCIS between January 1998 and December 2011
• Aim 2: DCIS patients who were diagnosed DCIS between January 2001 and December 2013

You may not qualify if…

• Aim 1: DCIS patients who received mastectomy as their first surgery
• Aim 2: DCIS patients who received BCS at the beginning yet received mastectomy in the end

Where it is running

• SEER-Medicare Dataset — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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