Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-30 @ 7:30 PM
Study NCT ID:
NCT05635266
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'C000655084', 'term': 'red meat allergy'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D000506', 'term': 'Alopecia Areata'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D019693', 'term': 'Hepatitis, Autoimmune'}, {'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D017086', 'term': 'beta-Thalassemia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D010392', 'term': 'Pemphigus'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-31', 'size': 1041545, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-03T12:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-11-22', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biospecimen & Clinical Data Collection', 'timeFrame': '10 years', 'description': 'To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration', 'Allergies', 'Alpha-Gal Syndrome', 'Alzheimer Disease', 'Amyloidosis', 'Ankylosing Spondylitis', 'Arthritis', 'Alopecia Areata', 'Asthma', 'Atopic Dermatitis', 'Autism', 'Autoimmune Hepatitis', "Behcet's Disease", 'Beta-Thalassemia', 'Cancer', 'Celiac Disease', 'Kidney Diseases', 'COPD', 'Crohn Disease', 'Cystic Fibrosis', 'Diabetes', 'Dravet Syndrome', 'DMD', 'Fibromyalgia', 'Graves Disease', 'Thyroid Diseases', 'Hepatitis', 'Hidradenitis Suppurativa', 'ITP', 'Leukemia', 'ALS', 'Lupus or SLE', 'Lymphoma', 'Multiple Sclerosis', 'Myasthenia Gravis', 'Heart Diseases', 'Parkinson Disease', 'Pemphigus Vulgaris', 'Cirrhosis', 'Psoriasis', 'Schizophrenia', 'Scleroderma', 'Sickle Cell Disease', 'Stroke', 'Ulcerative Colitis', 'Vasculitis', 'Vitiligo']}, 'descriptionModule': {'briefSummary': 'To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Health condition, exceptive condition, and control participants will be recruited by one or any of the following resources, but not limited to:\n\n* Use of online marketing where potential participants receive study information from the Sanguine's website or online participant referral program;\n* In the site investigators (or PI's) clinic; and/or\n* Through community advocacy programs.\n* Participant Referral", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons 18 to 85 years of age at the date of informed consent.\n* If presenting with a history of a specific condition, the diagnosis is confirmable in the medical record or may be confirmed using other forms of verification including self-reporting.\n* Understands the procedures and requirements of the study by providing written informed consent (or verbal assent if a legally authorized representative will sign the ICF), including consent for authorization for protected health information disclosure.\n\nExclusion Criteria:\n\n* Persons younger than 18 years of age or older than 85 years of age at the date of informed consent.\n* Receipt of blood products 30 days before the study blood draw.\n* Receipt of an investigational (unapproved) drug 30 days before the study blood draw.\n* A confirmable diagnosis of any medical condition that would increase potential phlebotomy risks.\n* Has donated a unit of blood within the last 2 months at the date of informed consent.'}, 'identificationModule': {'nctId': 'NCT05635266', 'briefTitle': 'Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanguine Biosciences'}, 'officialTitle': 'A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives', 'orgStudyIdInfo': {'id': 'SAN-BB-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health Condition Group', 'interventionNames': ['Diagnostic Test: Specimen sample']}, {'label': 'Exceptive Condition Group', 'interventionNames': ['Diagnostic Test: Specimen sample']}, {'label': 'Control Group', 'interventionNames': ['Diagnostic Test: Specimen sample']}], 'interventions': [{'name': 'Specimen sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'The study may require a tissue collection and/or a participant survey for participation. Most tissue collected will come from a blood draw; up to 100mL for the health condition group, 60mL for the exceptive condition group, and up to 180mL for the control group (if determined safe for the participant). Participant surveys may involve participant reported outcomes (PROs) or custom participant surveys.', 'armGroupLabels': ['Control Group', 'Exceptive Condition Group', 'Health Condition Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sanguine Biosciences', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}], 'centralContacts': [{'name': 'Carolyn Bidwell', 'role': 'CONTACT', 'email': 'study@sanguinebio.com', 'phone': '855.836.4759'}], 'overallOfficials': [{'name': 'Houman Hemmati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanguine Biosciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanguine Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}