Epidemiology of Young Lung Cancer - Survey (EoYLC)

This is a 100% Virtual (Remote) Study (Survey, and Voluntary Blood Donation) to Explore Potential Environmental, Lifestyle and Genetic Factors That May be Associated With Driver Mutations of Young Lung Cancer in the USA.

This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.

Study Overview

• Status: Active, not recruiting
• Conditions: NSCLC
• Intervention / Treatment: Other: Online Survey

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Keck School of Medicine
    • San Carlos, California, United States, 94070
      • Addario Lung Cancer Medical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A minimum of 250 subjects distributed with at least 50 subjects among the most common driver mutation groups will be enrolled into the study:

1. EGFR (del19 and L858R) - 50 subjects
2. ROS1 - 50 subjects
3. ALK - 50 subjects
4. KRAS - 50 subjects

5. Other Groups:

   1. Uncommon activating mutation for which specific targeted therapy exists (RET fusion, NTRK fusion, BRAF V600E, MET Exon14 skipping mutations, other activating EGFR mutations) - 25 subjects
   2. Non-targetable other mutations (p53, NF1, ATM, PIK3CA, RB, non-V600E BRAF, NTRK mutation) or no identified mutation. - 25 subjects Subjects with more than one mutation will be included.

Description

Inclusion Criteria:

1. Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment
2. Documentation of primary NSCLC, any stage
3. Less than 50 years of age at the time of NSCLC diagnosis
4. Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer
5. Willingness to undergo all study procedure
6. Provision of written informed consent

Exclusion Criteria:

1. Male or female aged less than 18 years; or less than the age of majority for their residential state
2. Greater than or equal to 50 years of age at the time of NSCLC diagnosis
3. No documentation of mutation testing
4. Unwilling to undergo all study procedures
5. Unable or unwilling to provide consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EGFR	Other: Online Survey; Epidemiological Survey (approx 200 questions)
ROS1	Other: Online Survey; Epidemiological Survey (approx 200 questions)
ALK	Other: Online Survey; Epidemiological Survey (approx 200 questions)
KRAS	Other: Online Survey; Epidemiological Survey (approx 200 questions)
NSCLC Other	Other: Online Survey; Epidemiological Survey (approx 200 questions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory epidemiology correlates	Exploratory correlations between all questionnaire variables (demographic factors, medical history, smoking history, early life exposures (child and mother), residential history, occupational history, menstrual and reproductive history, diet, and physical activity.	1 month

Collaborators and Investigators

• Sponsor: Addario Lung Cancer Medical Institute
• Collaborators: University of Southern California; Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Barbara Gitlitz, MD, University of Southern California; Principal Investigator: Jorge Nieva, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): December 10, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ALCMI-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No