Epidemiology of Young Lung Cancer - Survey

NCT04640259 | Active Not Recruiting

• 1 other identifier: ALCMI-004
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

EGFR

Other: Online Survey

ROS1

Other: Online Survey

ALK

Other: Online Survey

KRAS

Other: Online Survey

NSCLC Other

Other: Online Survey

Interventions

Online Survey OTHER

Epidemiological Survey (approx 200 questions)

ALK; EGFR; KRAS; NSCLC Other; ROS1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead
• University of Southern California: collaborator
• Ohio State University Comprehensive Cancer Center: collaborator

Study Sites (2)

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

Addario Lung Cancer Medical Institute

San Carlos, California, 94070, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

Study Officials

• Jorge Nieva, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Barbara Gitlitz, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 23, 2020
• Study Start: February 1, 2021
• Primary Completion: December 10, 2025
• Study Completion: March 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)