Lung Cancer Risk Assessment and Etiology

NCT06328621 | Completed DMC

• 3 other identifiers: 19594NCI-2021-05881P30CA033572
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Frequency of abnormal radiographic findings

  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

  Up to study completion

• Liquid biopsy (LB) test sensitivity

  Through study completion, an average of 5 years

Study Arms (1)

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; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Survey Administration OTHER

Complete survey

Observational (survey, biospecimen, medical record, CT)

Computed Tomography PROCEDURE

Undergo low-dose CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Observational (survey, biospecimen, medical record, CT)

Electronic Health Record Review OTHER

Review of medical records

Observational (survey, biospecimen, medical record, CT)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (survey, biospecimen, medical record, CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Never-smoking patients with and without lung cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Stacy W Gray

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 25, 2024
• Study Start: July 2, 2021
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)