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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05881 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19594 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| 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 |
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| 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 |
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:
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:
Documented informed consent of the participant
Exclusion Criteria:
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Never-smoking patients with and without lung cancer
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| Name | Affiliation | Role |
|---|---|---|
| Stacy W Gray | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood
| Computed Tomography | Procedure | Undergo low-dose CT |
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| Electronic Health Record Review | Other | Review of medical records |
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| Survey Administration | Other | Complete survey |
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| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |