Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 11:43 AM
Study NCT ID:
NCT05245266
Status:
UNKNOWN
Last Update Posted:
2023-03-27
First Post:
2022-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell-Based Noninvasive Prenatal Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-03-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of fetal cells recovered and quality of DNA data on each cell', 'timeFrame': '3 years', 'description': 'Outcome 1 is the number of cells identified as fetal by microscopic staining. This can be\n\nconverted to units based on volume. If 40 mL of blood is collected and f8 cells are designated as fetal based on microscopic staining, the results can be tabulated as follow: So a result is 8 cells are identified as fetal from one blood draw. This equals 0.2 cells identified per mL of maternal blood. If two or fewer cells are obtained, a blood redraw will be requested from the patient.'}, {'measure': 'Number of fetal cells recovered and quality of DNA data on each cell', 'timeFrame': '3 years', 'description': "Outcome measure 2 is the number of cells that yield high quality next generation\n\nsequencing data suitable for determining copy number across the entire genome. So if 4 of the 8 cells above gave high quality data, the outcome would be 4 cells with high quality copy number data from one blood draw which equals 0.10 high quality cell / mL of mother's b"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prenatal', 'genetic testing', 'noninvasive', 'diagnostic'], 'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': "The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All healthy pregnant female volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for healthy pregnant subjects:\n\n* Pregnant\n* 18 years or older\n* 65 or younger\n\nExclusion Criteria for healthy pregnant subjects:\n\n* Acute illness\n* Unavailability of maternal blood sample of at least 30 ml\n* Language barrier (non-English speaking )\n* Maternal age of less than 18 years, or over 65\n* Higher order multiple pregnancy (triplet or greater)'}, 'identificationModule': {'nctId': 'NCT05245266', 'acronym': 'NIPT', 'briefTitle': 'Cell-Based Noninvasive Prenatal Testing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luna Genetics'}, 'officialTitle': 'Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)', 'orgStudyIdInfo': {'id': 'Luna IRB LG-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Analysis of blood samples from healthy pregnant women', 'description': 'Analysis of blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.', 'interventionNames': ['Diagnostic Test: Redraw for analysis of blood samples from healthy pregnant women']}], 'interventions': [{'name': 'Redraw for analysis of blood samples from healthy pregnant women', 'type': 'DIAGNOSTIC_TEST', 'description': 'If less than two fetal cells are recovered from maternal blood, a redraw is indicated', 'armGroupLabels': ['Analysis of blood samples from healthy pregnant women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arthur Beaudet, MD', 'role': 'CONTACT', 'email': 'abeaudet@lunagenetics.com', 'phone': '713-202-7686'}, {'name': 'Arthur Beaudet, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Luna Genetics', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': "April O' Connor, MS, LCGC", 'role': 'CONTACT', 'email': 'aoconnor@lunagenetics.com', 'phone': '928-533-2429'}, {'name': 'Michelle Bellair, MSc.', 'role': 'CONTACT', 'email': 'mbellair@lunagenetics.com', 'phone': '3462177049'}], 'overallOfficials': [{'name': 'Arthur Beaudet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luna Genetics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luna Genetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}