A Review of Low-Dose CT Lung Cancer Screenings in a Community-Based Healthcare System With High Incidence
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/20/2018 |
| Start Date: | April 17, 2018 |
| End Date: | September 2018 |
An analysis of Low-Dose Cat Scan(LDCT) Screenings for Lung Cancer completed within the St.
Elizabeth system from January 2015 until February 2018. 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.
Elizabeth system from January 2015 until February 2018. 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.
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
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
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
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