Clinical trial · Observational
Lung Cancer Risk Assessment and Etiology
Lung Cancer Risk Assessment &Amp; Etiology
NCT06328621CI-TRIAL-00105846completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (survey, biospecimen, medical record, CT)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Other: Electronic Health Record Review
- Other: Survey Administration
Primary outcomes (1)
- measure
- Frequency of germline alterations
- timeFrame
- Through study completion, an average of 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.