A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence

NCT ID: NCT03560791

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7659 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2023-03-06

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

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Elizabeth Healthcare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Royce Calhoun, MD

Role: PRINCIPAL_INVESTIGATOR

St Elizabeth Healthcare

Locations

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21714641 (View on PubMed)

Other Identifiers

3/2018-022

Identifier Type: -

Identifier Source: org_study_id