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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04640259
Other study ID # ALCMI-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date December 30, 2026

Study information

Verified date February 2024
Source Addario Lung Cancer Medical Institute
Contact Richard Erwin
Phone 888-443-6952
Email rerwin@alcmi.net
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 30, 2026
Est. primary completion date December 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Online Survey
Epidemiological Survey (approx 200 questions)

Locations

Country Name City State
United States USC Keck School of Medicine Los Angeles California
United States Addario Lung Cancer Medical Institute San Carlos California

Sponsors (3)

Lead Sponsor Collaborator
Addario Lung Cancer Medical Institute Ohio State University Comprehensive Cancer Center, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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