Lung Cancer Risk Assessment and Etiology

March 16, 2026 updated by: City of Hope Medical Center

Lung Cancer Risk Assessment &Amp; Etiology

This study examines the biological and social determinants that may increase the risk for lung cancer in patients and never-smoking individuals. Biological characteristics of a person can include their genetics and social determinants of a person can include their education, income, and environment, all of which can impact their health. Information collected in this study may help increase early detection of lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess the frequency of germline cancer susceptibility mutations in affected and unaffected individuals who have a personal or family history suggestive of high lung cancer risk.

EXPLORATORY OBJECTIVES:

I. To assess the frequency of abnormal radiographic findings in high-risk individuals unaffected with cancer who undergo low-dose computed tomography (CT) screening.

II. Use patient survey and medical record data to explore the associations between social determinants of health, biological risk factors, family history and lung cancer incidence.

III. To determine the sensitivity and specificity of liquid biopsy for detection of lung cancer in a never-smoking population.

OUTLINE:

Participants complete a survey over 40-45 minutes at baseline and undergo collection of blood samples at a scheduled clinical or research blood draw. Participants' medical records are also reviewed. Participants not diagnosed with lung cancer (i.e. "unaffected"), undergo a low-dose computerized tomography (CT) scan over 20 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Never-smoking patients with and without lung cancer

Description

Inclusion Criteria:

  • Have had clinical germline genetic testing and/or have consented or expressed a willingness to consent to the City of Hope (COH) General Research Protocol COH IRB # 07047
  • Age >= 18 years
  • Willing to have about 30 mL of blood (approximately 2 tablespoons) drawn during the aspiration visit
  • Speak English, Spanish, or Mandarin

  • Lung cancer patients: meeting at least one of the following criteria:

    • Be a never-smoker with lung cancer (excludes atypical/typical carcinoid and small cell tumors)
    • Be diagnosed with lung cancer =< 50 years of age
    • Have a germline alteration known/suspected to be associated with elevated lung cancer risk
    • Have a strong family history of lung cancer (>= one first, second or third degree relative with never-smoking lung cancer, >= three first, second or third degree relative with lung cancer in one lineage [side of the family], >= one first, second or third degree relative diagnosed with lung cancer under the age of 50. Patients may also be considered eligible if they meet the family history criteria in part and have a truncated family structure [e.g., only one first and one second degree relative with lung cancer in a small family])

  • Unaffected patients (i.e., those without a lung cancer diagnosis and other cancer diagnosis for the past 5 years) who are at least 50 years of age or at most age 10 years younger than the first case of lung cancer in the family, meeting at least one of the following criteria:

    • Have a germline alteration known/suspected to be associated with elevated lung cancer risk
    • Have a strong family history of lung cancer (>= one first, second or third degree relative with never-smoking lung cancer, >= three first, second or third degree relative with lung cancer in one lineage [side of the family], >= one first, second or third degree relative diagnosed with lung cancer under the age of 50. Patients may also be considered eligible if they meet the family history criteria in part and have a truncated family structure [e.g., only one first and one second degree relative with lung cancer in a small family])
    • Of East Asian descent with any family history of lung cancer
  • Documented informed consent of the participant

Exclusion Criteria:

  • Unable to provide informed consent
  • Patients who fall under the unaffected cohort criteria but received chest imaging (except chest x-ray) within the last year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational (survey, biospecimen, medical record, CT)
Participants complete a survey over 40-45 minutes at baseline. Participants' medical records are also reviewed. Participants who have lung cancer but have not undergone treatment and participants not diagnosed with lung cancer (i.e., "unaffected"), undergo collection of blood samples at a scheduled clinical or research blood draw. Participants not diagnosed with lung cancer (i.e. "unaffected"), undergo a low-dose CT scan over 20 minutes.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Survey Administration
Complete survey
Other: Electronic Health Record Review
Review of medical records
Procedure: Computed Tomography
Undergo low-dose CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of germline alterations
Time Frame: Through study completion, an average of 5 years
We will explore the relationships between variables, examining correlations (Pearson or Spearman where appropriate). Summarization of data using univariate distributions of the outcomes of interest (presence of lung cancer and molecular phenotypes) and their bivariate distributions with social determinants of health will be carried out. We will examine whether financial hardship, low levels of education, and traffic proximity are associated with presence of lung cancer and molecular phenotypes by using T-tests to compare means and Fisher's exact test to compare proportions. We will also conduct logistic regression modeling to adjust for relevant covariates like race/ethnicity, age, and sex. If appropriate, we will use standard techniques such as sensitivity analyses or multiple imputation to handle missing data.
Through study completion, an average of 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of abnormal radiographic findings
Time Frame: Through study completion, an average of 5 years
Will assess the frequency of abnormal radiographic findings in high-risk individuals unaffected with cancer who undergo low-dose computed tomography (CT) screening. Will summarize data related to the frequency of abnormal radiographic findings in high-risk individuals who undergo low-dose CT screening.
Through study completion, an average of 5 years
Associations between molecular phenotypes, social determinants of health, and the presence of lung cancer and related outcomes
Time Frame: Up to study completion
Identification of associations of social determinants of health and risk factors with lung cancer using lung cancer cases and non cases (survey and medical record data).
Up to study completion
Liquid biopsy (LB) test sensitivity
Time Frame: Through study completion, an average of 5 years
Calculated by comparing the LB results with known cancer status. Results will be reported with their corresponding 95% confidence intervals.
Through study completion, an average of 5 years
LB test specificity
Time Frame: Through study completion, an average of 5 years
Calculated by comparing the LB results with known cancer status. Results will be reported with their corresponding 95% confidence intervals.
Through study completion, an average of 5 years
LB test positive predictive value
Time Frame: Through study completion, an average of 5 years
Calculated by comparing the LB results with known cancer status. Results will be reported with their corresponding 95% confidence intervals.
Through study completion, an average of 5 years
LB test negative predictive value
Time Frame: Through study completion, an average of 5 years
Calculated by comparing the LB results with known cancer status. Results will be reported with their corresponding 95% confidence intervals.
Through study completion, an average of 5 years
LB test accuracy comparing LB genetic mutations to those found on next generation sequencing (NGS)
Time Frame: Through study completion, an average of 5 years
LB test sensitivity and specificity, will be calculated by comparing the LB results with known cancer status. In addition to sensitivity and specificity, we will also examine other confusion matrix statistics, such as positive predictive value, negative predictive value, and test accuracy. Results will be reported with their corresponding 95% confidence intervals.
Through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City of Hope Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stacy W Gray, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19594 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2021-05881 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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