Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06659458
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D001483', 'term': 'Base Sequence'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in DNA sequence of EGFR gene', 'timeFrame': 'From enrollment to end of data analysis at 6 months', 'description': 'Subjects who have EGFR positive lung cancer will have their gene sequence compared to those that are EGFR negative and do not have lung cancer to look for differences in the sequence.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'EGFR gene'], 'conditions': ['Lung Cancer - Non Small Cell', 'EGFR Exon 19 Deletion Mutation']}, 'descriptionModule': {'briefSummary': 'EGFR gene mutations are some of the most commonly occurring mutations in non-small cell lung cancer. Investigators have developed a DNA instability model that estimates a risk score to assess the likelihood of an individual acquiring a cancer-linked mutation. The aim of this study is to collect blood from both those diagnosed with EGFR positive lung cancer and healthy individuals, evaluate their gene sequence surrounding the EGFR landscape and use the cancer positive and healthy sequences to validate the risk assessment model, which may one day be used to provide insight on susceptibility of getting EGFR positive lung cancer or potentially other cancer types.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female adult subjects who have EGFR positive lung cancer', 'genderDescription': 'Biologically born females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-100 years old\n* Biologically born female\n* Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)\n* No cancer diagnosis (Arm 2-health control)\n\nExclusion Criteria:\n\n* less than 18 years of age\n* Biologically born male\n* Incarcerated at the time of participation'}, 'identificationModule': {'nctId': 'NCT06659458', 'acronym': 'EGFR Lung Canc', 'briefTitle': 'Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Our Lady of the Lake Hospital'}, 'officialTitle': 'Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'LSUHSCIRB_7781'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EGFR Positive Lung Cancer', 'description': 'Subjects diagnosed with EGFR positive lung cancer', 'interventionNames': ['Other: blood draw', 'Other: Gene sequencing']}, {'label': 'Healthy Subjects', 'description': 'Subjects who do not have a cancer diagnosis', 'interventionNames': ['Other: blood draw', 'Other: Gene sequencing']}], 'interventions': [{'name': 'blood draw', 'type': 'OTHER', 'description': 'A 10ml Blood sample will be taken and used to sequence the EGFR gene and surrounding DNA.', 'armGroupLabels': ['EGFR Positive Lung Cancer', 'Healthy Subjects']}, {'name': 'Gene sequencing', 'type': 'OTHER', 'description': 'Subjects will have their DNA sequenced within and around the EGFR gene.', 'armGroupLabels': ['EGFR Positive Lung Cancer', 'Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Our Lady of the Lake Regional Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'centralContacts': [{'name': 'Cynthia Knox, MBA', 'role': 'CONTACT', 'email': 'Cynthia.Knox@fmolhs.org', 'phone': '225-765-3344'}, {'name': 'Christine LeBoeuf, DNP', 'role': 'CONTACT', 'email': 'Christine.Leboeuf@fmolhs.org', 'phone': '225-763-5956'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be available and shared with collaborators upon completion of gene sequencing analysis of the final subject and remain available until IRB closure.', 'ipdSharing': 'YES', 'description': 'The demographic variables of age, race and gender will be shared with our external collaborator at Louisiana State University, Dept of Chemical Engineering in order to draw broad conclusions about the sequencing data and to use these general categories for presentation and publication. Data will be de-identified upon sharing.', 'accessCriteria': 'Only de-identified data will be shared with collaborators for the purpose of drawing conclusions and publication. Data will be sharing through a secure FileS system which is a HIPAA compliant platform offered by LSUHSC which limits access to only those for which the data is sent and does so in a secure manner.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Our Lady of the Lake Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research', 'investigatorFullName': 'Leslie Son', 'investigatorAffiliation': 'Our Lady of the Lake Hospital'}}}}