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NCT02908178 · ClinicalTrials.gov registry record
Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 28,291
- Enrollment target
NCT02908178: Completed study, sponsored by Yale University.
NCT02908178 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 28,291 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02908178 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 28,291 participants
- Enrollment target
Study Summary
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
Primary Outcome
Primary outcomes for Aim 1: Acute and subacute side effects include any complication, lymphedema, seroma, wound infection, and pain.
Interventions
- PROCEDURE Sentinel lymph node biopsy (SLNB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28,291 participants |
| Start Date | 2017-01-25 |
| Est. Completion | 2018-06-29 |
What the finished NCT02908178 record still lists
NCT02908178 is an observational study that tracks outcomes without assigning an intervention. Its 28,291 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Sentinel lymph node biopsy (SLNB) is the first listed.
NCT02908178 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02908178 about?
NCT02908178 is a clinical study titled "Comparative Effectiveness of Sentinel Lymph Node Biopsy for Ductal Carcinoma In Situ". 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 strategi...
What is the current status of trial NCT02908178?
This trial is currently completed. The enrollment target is 28,291 participants. The study started on 2017-01-25. Estimated completion is 2018-06-29.
What interventions are being tested in trial NCT02908178?
The interventions under investigation include: Sentinel lymph node biopsy (SLNB) (PROCEDURE).
Who is sponsoring clinical trial NCT02908178?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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