Lung Cancer Risk Assessment and Etiology

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: Completed
• Conditions: Lung Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Other: Electronic Health Record Review; Procedure: Computed Tomography

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: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Frequency of germline alterations	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

Outcome Measure	Measure Description	Time Frame
Frequency of abnormal radiographic findings	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	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	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	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	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	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)	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

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stacy W Gray, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): March 13, 2026
• Study Completion (Actual): March 13, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID 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