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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03563976
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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
Lung Cancer 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)


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Study Type : Observational
Estimated Enrollment : 200 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 : February 18, 2015
Estimated Primary Completion Date : March 20, 2025
Estimated Study Completion Date : March 15, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • Other: Retrospective Study
    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 Outcome Measures :
  1. POTENTIAL BENEFITS: [ Time Frame: 10 years ]
    Statistical Analyses will be performed for all subjects having received at least one fraction of radiation.The study will use the CTCAE version 4.0 for reporting of acute and late adverse events related to Lung will be reported by the physician through exam/assessment during research visit, encompassing events since last research visit. Research will collect and log lung related events for up to 10 years. Information gained from this study could lead to improved medical care for similar patients in the future.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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 information will include the parameters attached in the spreadsheet supplied with the IRB submission. 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.

Criteria

Inclusion Criteria:

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

2Patients are greater than 18 years of age.

3)Patients understand a written informed consent document and are willing to sign the consent form.

4)The tumor must be ineligible for definitive surgical resection.

Exclusion Criteria:

  1. Women who are pregnant or trying to get pregnant
  2. Children (under age of 18)
  3. The tumor must be ineligible for stereotactic body radiation therapy.
  4. Chemotherapy given within one week of study registration.
  5. Evidence of small cell histology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563976


Locations
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United States, Texas
UT Southwestern Medical Centre
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03563976     History of Changes
Other Study ID Numbers: STU 122014-052
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas Southwestern Medical Center:
Early Stage Lung Cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases