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NCT Number: NCT03563976

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Sarah Neufeld

CONTACT

[email protected]

214-648-1836

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kajal Desai, MS

CONTACT

[email protected]

2146458525

Sarah Neufeld, MS

CONTACT

[email protected]

214-648-1836

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2029
Study completion
2031
First posted
Jun 20, 2018
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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