Dysautonomia International

A Study of Lung Cancer Risk

Purpose

The researchers are doing this study to learn more about factors that may increase the risk of lung cancer in people who have never smoked. This information may help predict which people who have never smoked may be more likely to get lung cancer.

Condition

Lung Cancer

Eligibility

Eligible Ages: Between 40 Years and 74 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Criteria

Criteria:

- Female at birth

- Age 40-74 years

- No smoking history

- Participants must be never-smokers, defined as having smoked <100 cigarettes in
their lifetime

- Documentation of disease - case patients

o Case patients must have pathologically confirmed primary lung adenocarcinoma. New
and prevalent cases will be eligible. Case patients with a history of prior non-lung
cancer will be eligible for the study unless actively being diagnosed or treated for
another form of cancer at the time of enrollment.

- Criteria for control participants

- Control participants must have no personal history of lung cancer, symptoms
suspicious for lung cancer, or suspicious pulmonary nodules. Participants
recruited as controls and found on imaging to have lesions suspicious for lung
cancer will be excluded from analysis and followed prospectively. Data
regarding these participants will be reported in a sensitivity analysis.
Additional control participants will be recruited to ensure balanced age- and
race-matched enrollment by frequency matching. Control participants with a
history of prior non-lung cancer will be eligible for the study unless actively
being diagnosed or treated for another form of cancer at the time of
enrollment.

Study Design

Phase
Study Type: Observational
Observational Model: Case-Control
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Case patients	Must have pathologically confirmed primary lung adenocarcinoma.	Other: Questionnaire The study questionnaire will be administered at a regular treatment visit for case patients and at a study-specific visit for control participants. At the same visit, 1 vial of blood will be collected for genomic analysis for research purposes from both case patients and control participants. Collection of demographic information and exposure data.
Control participants	Must have no personal history of lung cancer, symptoms suspicious for lung cancer, or suspicious pulmonary nodules.	Other: Questionnaire The study questionnaire will be administered at a regular treatment visit for case patients and at a study-specific visit for control participants. At the same visit, 1 vial of blood will be collected for genomic analysis for research purposes from both case patients and control participants. Collection of demographic information and exposure data.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 07920