Lung Cancer Risk Assessment and Etiology

Last updated: July 29, 2025
Sponsor: City of Hope Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Carcinoma

Treatment

Survey Administration

Biospecimen Collection

Computed Tomography

Clinical Study ID

NCT06328621
19594
19594
NCI-2021-05881
P30CA033572
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have had clinical germline genetic testing and/or have consented or expressed awillingness 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 theaspiration 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 andsmall cell tumors)

  • Be diagnosed with lung cancer =< 50 years of age

  • Have a germline alteration known/suspected to be associated with elevated lungcancer risk

  • Have a strong family history of lung cancer (>= one first, second or thirddegree relative with never-smoking lung cancer, >= three first, second or thirddegree relative with lung cancer in one lineage [side of the family], >= onefirst, second or third degree relative diagnosed with lung cancer under the ageof 50. Patients may also be considered eligible if they meet the family historycriteria in part and have a truncated family structure [e.g., only one firstand one second degree relative with lung cancer in a small family])

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

  • Have a germline alteration known/suspected to be associated with elevated lungcancer risk

  • Have a strong family history of lung cancer (>= one first, second or thirddegree relative with never-smoking lung cancer, >= three first, second or thirddegree relative with lung cancer in one lineage [side of the family], >= onefirst, second or third degree relative diagnosed with lung cancer under the ageof 50. Patients may also be considered eligible if they meet the family historycriteria in part and have a truncated family structure [e.g., only one firstand 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

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 Design

Total Participants: 109
Treatment Group(s): 4
Primary Treatment: Survey Administration
Phase:
Study Start date:
July 02, 2021
Estimated Completion Date:
June 15, 2029

Study 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.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Site Not Available

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