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Clinical Trials/NCT03563976
NCT03563976RecruitingNot Applicable

Multi Parametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer

University of Texas Southwestern Medical Center2 sites in 1 country2,000 target enrollmentStarted: February 18, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,000
Locations
2
Primary Endpoint
Determine whether CT-based multiparametric analytical models may improve prediction of biopsy and treatment outcome in patients undergoing screening CT scan and/or treatment for early stage lung cancer

Study Overview

Brief Summary

Determine whether CT-based multiparametric analytical models may improve prediction of biopsy and treatment outcome in patients undergoing screening CT scan and/or treatment for early stage lung cancer

Detailed Description

The hypothesis is that multiparametric models that incorporate complex image information from screening CT scans will improve prediction of the outcome of subsequent lung biopsy, an invasive diagnostic procedure. In this project, we will construct an image feature-based multiparametric prognostic model for biopsy outcome from screening lung CT scans performed at our institution, and then validate it using theNLST imaging and clinical outcomes dataset.

This study involves no treatment or invasive procedures. Investigator will review all charts of patients who were treated for early stage lung cancer with definitive radiation therapy at UTSW or Parkland Memorial hospital, diagnosed with a malignancy from January 1, 2004 to October 31, 2014, to compile demographic, diagnostic, therapeutic, outcome, and toxicity data. Investigator expect that this will include approximately 200 patient charts. This data will be analyzed statistically and used for future directed research. Investigator will also analyze an anonymized dataset of patients from the National Lung Cancer Screening Trial (NLST) provided by the National Cancer Institute (NCI)

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW or Parkland Memorial Hospital.

Exclusion Criteria

  • There will be no absolute exclusion criteria as long as the inclusion criteria have been met.

Outcomes

Primary Outcomes

Determine whether CT-based multiparametric analytical models may improve prediction of biopsy and treatment outcome in patients undergoing screening CT scan and/or treatment for early stage lung cancer

Time Frame: 10 years

We will review all charts of patients who were treated for early stage lung cancer with definitive radiation therapy at UTSW or Parkland Memorial hospital, diagnosed with a malignancy from January 1, 2004 to October 31, 2014, to compile demographic, diagnostic, therapeutic, outcome, and toxicity data. The data will be subject to standard descriptive, parametric, and nonparametric hypothesis testing with biostatistical analyses. We will also analyze an anonymized dataset of patients from the National Lung Cancer Screening Trial (NLST) provided by the National Cancer Institute (NCI) including screening images and diagnostic outcomes to validate models generated using institutional data.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jing Wang

Associate Professor of Medicine

University of Texas Southwestern Medical Center

Study Sites (2)

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