Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT05889806
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-05
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'This Study will collect leftover Specimens that are taken during standard medical care procedures (for example, tissues, whole teeth, blood, saliva, urine, fluids, and cells). Samples will first be processed for clinical purposes, and any discarded portions of the Specimen(s) will be provided to the Sponsor for the Study purposes.\n\nNon-Surplus Specimens Types to be Collected for Study:\n\nBlood Tooth Bone marrow aspirate Aqueous humor Urine Perineal specimens Rectal specimens Urethral specimens Nasal/Nasopharyngeal and throat specimens Cheek (buccal) specimens Saliva (Sputum) Oral rinse Stool samples Vaginal and cervical specimens Endometrial (uterus) samples Vaginal lavage (wash)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2043-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-02', 'studyFirstSubmitDate': '2023-05-25', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2043-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment and collection totals for a diverse population of subjects/conditions involved in diseases and in healthy/control populations.', 'timeFrame': 'Through study completion, an average of once per year', 'description': 'We will total the number of subjects and characterize the totals by disease state, gender, ethnicity and specimens contributed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology', 'Hematologic Malignancy', 'Gastro-Intestinal Disorder', 'Autoimmune Diseases', 'Pregnancy Related', 'Infectious Disease', 'Cardiovascular Diseases', 'Genitourinary Disease', 'Renal Disease']}, 'descriptionModule': {'briefSummary': 'Study purpose: to explore the entire spectrum of proteomic and genomic changes (amongst others) involved in diseases and in healthy/control populations. The Study is designed to discover biomarkers, develop and validate diagnostic assays, instruments and therapeutics as well as other medical research. Specifically, researchers may analyze proteins, RNA, DNA copy number changes, including large and small (1,000-100,000 kb) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both diseased tissue and case-matched germline DNA from Subjects.', 'detailedDescription': 'The primary objective of this Study is to collect high-quality tissue, whole teeth, and biofluid Specimens, and associated Clinical Data from consented Subjects.\n\nThe secondary objective of this Study is to test Specimens and associated Clinical Data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess RNA and DNA integrity or degradation, and provide overall quality control evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include willing participants that are able to provide consent (or have an LAR to provide consent on their behalf), the requested biospecimens and associated data.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject shall be at least 18 years of age, or higher if required by Applicable Law.\n2. Subject's Clinical Data shall be relevant to the Study in which he/she is participating.\n3. Subject shall understand and voluntarily sign the ICF prior to the Study participation. If the Subject is illiterate, the witness must sign the ICF (see 5.6. for details). If the Subject is incapable of consenting himself/herself, the legally authorized representative must sign the ICF (see 5.6. for details).\n4. Subject shall meet any other additional inclusion criteria specified in Appendices to this Protocol, or in additional written instructions of the Sponsor.\n5. Subject shall be able to donate the requested Specimen(s) without compromising his/her current health status.\n\nExclusion Criteria:\n\n1. Younger than 18 years of age, or higher if required by Applicable Law.\n2. The individual is incapable of understanding the items listed in the ICF and the consent process unless consented by the legally authorized representative.\n3. Prisoner"}, 'identificationModule': {'nctId': 'NCT05889806', 'briefTitle': 'AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Audubon Bioscience'}, 'officialTitle': 'AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)', 'orgStudyIdInfo': {'id': 'US005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Healthy subjects with no history of chronic disease', 'interventionNames': ['Other: Observational Study Only. NO Intervention.']}, {'label': 'Subjects with various conditions', 'description': 'Subjects that have been diagnosed with a condition of interest such as Diabetes, NASH, Breast Cancer, Endometriosis, or other designated condition.', 'interventionNames': ['Other: Observational Study Only. NO Intervention.']}], 'interventions': [{'name': 'Observational Study Only. NO Intervention.', 'type': 'OTHER', 'description': 'Observational Study Only. NO Intervention.', 'armGroupLabels': ['Healthy', 'Subjects with various conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'AUD', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Audubon Bioscience', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}