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

Non-small Cell Lung Cancer Clinical Trial

— REACH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03560791
• Other study ID #: 3/2018-022
• Status: Enrolling by invitation
• Start date: April 17, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: St Elizabeth Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
United States	St. Elizabeth Healthcare	Edgewood	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
St Elizabeth Healthcare

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nodule Categories		From first LDCT through final LDCT up to 6 years
Other	Cancer Diagnosis		From detection of nodule through diagnostic pathology result up to 6 years
Other	Stage of cancer diagnosis		From detection of nodule through diagnostic pathology result up to 6 years
Other	Presentation in Tumor Board		From diagnosis of cancer through completion of treatment up to 6 years
Other	Presentation in Nodule Review Board		From detection of category 4 nodule through completion of screening up to 6 years
Other	Referral Date for LDCT		From identification of eligible patient through LDCT screen completion up to 1 year
Primary	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	Additional Imaging caused by LDCTs		From patient referral through last radiographic image up to 6 years
Secondary	Additional Procedures caused by LDCTs		From evidence of concerning nodule through completion of treatment up to 6 years
Secondary	Adverse Events caused by LDCTs		From first screen through last treatment intervention for the nodule up to 6 years