Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-31 @ 6:13 PM
Study NCT ID:
NCT05669105
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2022-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-12-13', 'studyFirstSubmitQcDate': '2022-12-28', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biospecimen & Clinical Data Collection', 'timeFrame': '10 years', 'description': 'The primary objective is to collect 2000 whole blood samples from subjects who are diagnosed with active lung cancer.\n\nThe purpose of this study is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with various active lung cancers so that investigations can analyze how the immune response can take place, and aid in understanding active lung cancer biomarkers for future early diagnosis and treatment options.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'NSCLC'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The study objective is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with active lung cancer to investigate the immune response to develop treatments and therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll up to 200 participants. Recruitment will occur through Sanguine advertisements, partnerships with cancer foundations, and cancer centers. Participants may be contacted for future studies.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants willing and able to provide written informed consent\n* Participants are willing and able to provide appropriate photo identification\n* Participant's age 18 - 100 years old\n* Participants diagnosed with active non-small cell lung cancer (Adenocarcinoma or Squamous Cell only. All stages are acceptable.)\n* Participants must have associated tissue biomarker data (EFGR and MET mutations) in their medical records\n\nExclusion Criteria:\n\n* Participants who are pregnant or nursing\n* Participants with a known history of HIV, hepatitis, or other infectious diseases\n* Participants who have taken an investigational product in the last 30 days\n* Participants who have experienced excess blood loss, including blood donation defined as 250 mL in the last month or 500 mL in the previous two months\n* Participants currently enrolled in a clinical trial\n* Participants currently in remission"}, 'identificationModule': {'nctId': 'NCT05669105', 'briefTitle': 'Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanguine Biosciences'}, 'officialTitle': 'Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research', 'orgStudyIdInfo': {'id': 'SAN-08877'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Specimen sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will have up to 100 mL of whole blood collected.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thomas Goslin', 'role': 'CONTACT', 'email': 'tgoslin@sanguinebio.com', 'phone': '818-583-8844'}, {'name': 'Houman Hemmati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sanguine Biosciences', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'centralContacts': [{'name': 'Thomas Goslin', 'role': 'CONTACT', 'email': 'tgoslin@sanguinebio.com', 'phone': '(818) 583-8844'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanguine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}