Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04640259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Young Lung Cancer - Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exploratory epidemiology correlates', 'timeFrame': '1 month', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A minimum of 250 subjects distributed with at least 50 subjects among the most common driver mutation groups will be enrolled into the study:\n\n1. EGFR (del19 and L858R) - 50 subjects\n2. ROS1 - 50 subjects\n3. ALK - 50 subjects\n4. KRAS - 50 subjects\n5. Other Groups:\n\n 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\n 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment\n2. Documentation of primary NSCLC, any stage\n3. Less than 50 years of age at the time of NSCLC diagnosis\n4. Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer\n5. Willingness to undergo all study procedure\n6. Provision of written informed consent\n\nExclusion Criteria:\n\n1. Male or female aged less than 18 years; or less than the age of majority for their residential state\n2. Greater than or equal to 50 years of age at the time of NSCLC diagnosis\n3. No documentation of mutation testing\n4. Unwilling to undergo all study procedures\n5. Unable or unwilling to provide consent'}, 'identificationModule': {'nctId': 'NCT04640259', 'acronym': 'EoYLC', 'briefTitle': 'Epidemiology of Young Lung Cancer - Survey', 'organization': {'class': 'OTHER', 'fullName': 'Addario Lung Cancer Medical Institute'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'ALCMI-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EGFR', 'interventionNames': ['Other: Online Survey']}, {'label': 'ROS1', 'interventionNames': ['Other: Online Survey']}, {'label': 'ALK', 'interventionNames': ['Other: Online Survey']}, {'label': 'KRAS', 'interventionNames': ['Other: Online Survey']}, {'label': 'NSCLC Other', 'interventionNames': ['Other: Online Survey']}], 'interventions': [{'name': 'Online Survey', 'type': 'OTHER', 'description': 'Epidemiological Survey (approx 200 questions)', 'armGroupLabels': ['ALK', 'EGFR', 'KRAS', 'NSCLC Other', 'ROS1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94070', 'city': 'San Carlos', 'state': 'California', 'country': 'United States', 'facility': 'Addario Lung Cancer Medical Institute', 'geoPoint': {'lat': 37.50716, 'lon': -122.26052}}], 'overallOfficials': [{'name': 'Jorge Nieva, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Barbara Gitlitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addario Lung Cancer Medical Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}