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Clinical Trial Details
Before-After Operational Data Collection Study Protocol - UConn
Clinical Trial ( IRB ) #: 24-094-1
Title: Before-After Operational Data Collection Study Protocol - UConn
Principal Investigator: Dr. Omar Ibrahim
Description: The diagnosis managment of lung nodules can be difficult. Current guidelines recommend that pulmonary nodules are managed based upon their probability of malignancy. Despite established guidelines, prior studies estimate that 60-70% of patients with ILNs are not followed up in a timely fashion in accordance with guidelines. To address the management and diagnostic challenges, Optellum has developed Virtual Nodule Clinic (VNC). VNC is an FDA-cleared, web-based, end-to-end software solution early lung cancer diagnosis. University of Connecticut Health (UConn) will be using VNC for routine clinical management of pulmonary nodule patients. As such, UConn offers an ideal environment in which to evaluate the real-world clinical utility of VNC. As part of this partnership, UConn will work with Optellum to evaluate whether use of VNC leads to an improvement in the number of pulmonary nodule patients being followed up and in the pulmonary nodule care pathway. All patients enrolled in UConn';s pulmonary nodule clinic will be eligible. The number of subjects with data collection is unspecified and will depend on the number of patients seen during different phases of the study. The data collection will have three parts: Phase 1: Baseline pre-VNC installation: operational data will be extracted from patient charts up to 6 months prior to the ';Go live'; date of Optellum';s VNC at UConn. Ramp-up period: This is the period during which UConn VNC users are being trained and migrating from their existing workflow, while the VNC workflow is being customized to their feedback. Phase 2: Active Patient Discovery post-VNC installation: operational data will be collected for the 3-12 months post-installation of VNC. During this time the Patient Discovery feature of VNC will be in active use by UConn VNC users.
  Breathing and Lung
  Cancer - Lung
Eligibility Criteria: Check with study contact
How to Contact: Quratulain Ali. Telephone: 860-679-7648. Email: Qali@uchc.edu or Maria Ortiz Ramirez. Telephone: 860-679-1144. Email: maortiz@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.