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

NCT03560791 | Completed

• 1 other identifier: 3/2018-022
• Study Type: observational
• Target: 7,659
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Date(s) of LDCT

  When the patient completed the LDCT(s)

  From patient referral for LDCT to completion of screening up to 1 year

Secondary Outcomes (3)

• Additional Imaging caused by LDCTs

  From patient referral through last radiographic image up to 6 years

• Additional Procedures caused by LDCTs

  From evidence of concerning nodule through completion of treatment up to 6 years

• Adverse Events caused by LDCTs

  From first screen through last treatment intervention for the nodule up to 6 years

Other Outcomes (6)

• Nodule Categories

  From first LDCT through final LDCT up to 6 years

• Cancer Diagnosis

  From detection of nodule through diagnostic pathology result up to 6 years

• Stage of cancer diagnosis

  From detection of nodule through diagnostic pathology result up to 6 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St Elizabeth Healthcare: lead

Study Sites (1)

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Related Publications (1)

• 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.

  PMID: 21714641 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Royce Calhoun, MD

  St Elizabeth Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 18, 2018
• Study Start: April 6, 2018
• Primary Completion: December 31, 2021
• Study Completion: March 6, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)