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

NCT03563976 | Recruiting DMC

• 1 other identifier: STU 122014-052
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

Early Stage Lung Cancer

Outcome Measures

Primary Outcomes (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

  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.

  10 years

Interventions

Retrospective Study OTHER

The medical charts are the subjects. The institutional charts will be identified by the use of definitive radiation therapy correlating with an early stage lung cancer diagnosis during the above time frame. The data from these charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, date of birth, and social security number. These are all patients treated by all hospitals and clinics affiliated with UTSW and Parkland. At the time of study, some of the patients will have expired but some will be alive and in the regional North Texas area. Thus, given the minimal risk nature of this retrospective chart review, we could not reasonably conduct this research with a full waiver of consent. The NLST external dataset is proved by the NCI, with no identifying characteristics.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The medical charts are the subjects. Risk will be minimized by protecting patient data through the use of de-identification of patient identifiers and password protected data collection. The information will be given only to faculty members and statisticians involved in the research project. The data will be disclosed only for analytical purposes. Confidentiality will be maintained by adhering to HIPAA guidelines. The location of the data will be maintained at the worksite of the PI and the research coordinator in the Moncrief Radiation Oncology Department on the North Campus at UTSW. Risks will be minimized by protecting patient data and using it only for research purposes for retrospective analysis.

You may qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jing Wang, MD

  UTSW Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Neufeld, MS

CONTACT

214-648-1836; Sarah.hardee@UTSouthwestern.edu

Kajal Desai, MS

CONTACT

2146458525; kajal.desai@utsouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 20, 2018
• Study Start: February 18, 2015
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)