EoYLC: Epidemiology of Young Lung Cancer - Survey

• Sponsor: Addario Lung Cancer Medical Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04640259
• Collaborator: University of Southern California (Other), Ohio State University Comprehensive Cancer Center (Other)
• Enrollment: 250
• Locations: 2
• Anticipated Duration (Months): 21.9
• Patients Per Site: 125
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Other: Online Survey

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: 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.
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Exploratory epidemiology correlates [1 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Keck School of Medicine	Los Angeles	California	United States	90033
2	Addario Lung Cancer Medical Institute	San Carlos	California	United States	94070

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Addario Lung Cancer Medical Institute
• ClinicalTrials.gov Identifier: NCT04640259
• Other Study ID Numbers: ALCMI-004
• First Posted: Nov 23, 2020
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 16, 2022