Clinical trial NCT03560791: A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence
Official title: A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: St Elizabeth Healthcare
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 7659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients within St Elizabeth Healthcare who are referred for and/or have completed a LDCT from January 2015-February 2018

Brief summary: An analysis of Low-Dose Cat Scan(LDCT) Screenings for Lung Cancer completed within the St. Elizabeth system from January 2015 until December 2019. The study investigator, or designee(s), will retrospectively review patient encounters, collecting data related to LDCT referrals and completions. Data analysis will focus on the subsequent imaging, procedures, reviews at The Nodule Review Board and Lung Cancers diagnosed as a result of the LDCT.

Detailed description: This study is a single center, minimal risk, physician initiated retrospective chart review. Potential subjects will be identified using records provided by the St. Elizabeth Healthcare Thoracic Oncology and Radiology Department. Potential subjects will be screened for eligibility. Study investigator and designees will review patient electronic medical records, extracting data related to the ordering/completion of a LDCT and interventions that occurs thereafter. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments. Please see Appendix A for a complete list of data points. All of the data that will be collected for study purposes will be kept confidential. This will be attained by the following: First, each enrolled subject will be assigned a study specific serial number for the database. All study documents and data collection tools will be maintained with the investigative site file in a locked cabinet in a secure location maintained by the investigator. The database will not include the patient's name or hospital medical record number. No one will have access to the database but the study principal investigator and study staff designated by the principal investigator. However, study data may be reviewed by the Institutional Review Board of record, an appointed study monitor, an internal auditor for St. Elizabeth Healthcare, and necessary regulatory authorities. The security of the database will be maintained under the direction of the principal investigator. Fourth, when the study is completed, the manuscript is published, and IRB storage document requirements have been met, the file will be permanently deleted and destroyed

Eligibility criteria: Inclusion Criteria:

* Patients within St Elizabeth Healthcare who are referred for and/or have completed a LDCT from January 2015-February 2018
* \>=18 years of age

Exclusion Criteria:

• Patient undergoes subsequent imaging, procedures and/or treatment at a facility outside of St. Elizabeth where records are not available through EPIC

Primary outcomes:
measure: Date(s) of LDCT
timeFrame: From patient referral for LDCT to completion of screening up to 1 year
Secondary outcomes:
measure: Additional Imaging caused by LDCTs
timeFrame: From patient referral through last radiographic image up to 6 years
measure: Additional Procedures caused by LDCTs
timeFrame: From evidence of concerning nodule through completion of treatment up to 6 years
measure: Adverse Events caused by LDCTs
timeFrame: From first screen through last treatment intervention for the nodule up to 6 years
Other outcomes:
measure: Nodule Categories
timeFrame: From first LDCT through final LDCT up to 6 years
measure: Cancer Diagnosis
timeFrame: From detection of nodule through diagnostic pathology result up to 6 years
measure: Stage of cancer diagnosis
timeFrame: From detection of nodule through diagnostic pathology result up to 6 years
measure: Presentation in Tumor Board
timeFrame: From diagnosis of cancer through completion of treatment up to 6 years
measure: Presentation in Nodule Review Board
timeFrame: From detection of category 4 nodule through completion of screening up to 6 years
measure: Referral Date for LDCT
timeFrame: From identification of eligible patient through LDCT screen completion up to 1 year
Locations:
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
Study officials:
affiliation: St Elizabeth Healthcare
name: Royce Calhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.