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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03563976
Collaborator
(none)
1,000
1
156.8
6.4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Retrospective Study

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
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Multi Parametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer
Actual Study Start Date :
Feb 18, 2015
Anticipated Primary Completion Date :
Mar 20, 2026
Anticipated Study Completion Date :
Mar 15, 2028

Outcome Measures

Primary Outcome Measures

  1. 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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW.

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Southwestern Medical Center Dallas Texas United States 75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Jing Wang, MD, UTSW Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jing Wang, Associate Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03563976
Other Study ID Numbers:
  • STU 122014-052
First Posted:
Jun 20, 2018
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jing Wang, Associate Professor of Medicine, University of Texas Southwestern Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022