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NCT02835599 · ClinicalTrials.gov registry record
Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now
A clinical trial, sponsored by AstraZeneca.
- Terminated
- Registry status
- 23
- Enrollment target
NCT02835599: Clinical Trial study, sponsored by AstraZeneca.
NCT02835599 is a clinical trial that was terminated before completion, run by AstraZeneca. The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02835599 was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- 23 participants
- Enrollment target
Study Summary
REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrolling approximately 2,500 patients. Additional patients limited to those with EGFR mutations may be enrolled following the initial study period as needed to ensure adequate sample sizes needed to examine primary questions of interest in the EGFR mutant population. Patients will be enrolled over a three year period across approximately 25 geographically diverse academic as well as community based sites within the US. The five year follow-up period will ensure robust survival data for correlations with clinical, tumor, and treatment variables. The target of 2,500 patients is meant to ensure adequate numbers of NSCLC patients with particular characteristics of interest including patients with adenocarcinoma, and EGFR mutations and effectively evaluate these patients with respect to key outcomes of interest including overall survival, time to progression, stage at progression, secondary metastases including brain metastases (at diagnosis and progression), comorbidity burden, and performance status at index date. The study design allows a cross-sectional perspective with collection of detailed patient and clinical characteristics at enrollment followed by longitudinal assessment of clinician and patient-reported endpoints every three months. Centralized follow-up will be conducted by having sites upload patient data following each visit via the web-based data system, with patients who do not show up for site visits being contacted via telephone by the Duke Clinical Research Institute (DCRI) call center. Site recruitment and patient enrollment will be weighted based upon provider specialty and ability to enroll patients with NSCLC with the specified inclusion criteria.
Primary Outcome
Characterize current practice patterns for the care of patients with NSCLC, with a special emphasis on pharmacotherapy (i.e. chemotherapy, targeted agents, and immunotherapy) and patients with EGFR mutated disease. These data will include treatment, molecular test administration and results, provider decisions and patient preferences, and explore the determinants of each.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-11-01 |
| Est. Completion | 2017-04-06 |
Why NCT02835599 stopped before completion
NCT02835599 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02835599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02835599 about?
NCT02835599 is a clinical study titled "Registry for the EVolution Of LUng Cancer Therapy Implementation and Outcomes Now". REVOLUTION will be a US multicenter observational registry in scope and governed by a steering committee of approximately 8 experts in NSCLC and outcomes research. The primary goal of the registry is characterizing patterns of use for NSCLC therapy. REVOLUTION will be a multicenter registry enrollin...
What is the current status of trial NCT02835599?
This trial is currently terminated. The enrollment target is 23 participants. The study started on 2016-11-01. Estimated completion is 2017-04-06.
Who is sponsoring clinical trial NCT02835599?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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