Clinical trial NCT06328621: Lung Cancer Risk Assessment and Etiology
Official title: Lung Cancer Risk Assessment &Amp; Etiology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Never-smoking patients with and without lung cancer

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of germline alterations
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
measure: Frequency of abnormal radiographic findings
timeFrame: Through study completion, an average of 5 years
measure: Associations between molecular phenotypes, social determinants of health, and the presence of lung cancer and related outcomes
timeFrame: Up to study completion
measure: Liquid biopsy (LB) test sensitivity
timeFrame: Through study completion, an average of 5 years
measure: LB test specificity
timeFrame: Through study completion, an average of 5 years
measure: LB test positive predictive value
timeFrame: Through study completion, an average of 5 years
measure: LB test negative predictive value
timeFrame: Through study completion, an average of 5 years
measure: LB test accuracy comparing LB genetic mutations to those found on next generation sequencing (NGS)
timeFrame: Through study completion, an average of 5 years
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Stacy W Gray
role: PRINCIPAL_INVESTIGATOR
References: