Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 12:01 PM
Study NCT ID:
NCT00871195
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Noninvasive Test for Fetal RHD Genotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma and buffy coat.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-09', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.', 'timeFrame': 'First, second, and third trimester'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhesus D', 'RHD', 'genotype', 'phenotype', 'neonatal', 'noninvasive', 'fetal', 'MassARRAY', 'DNA'], 'conditions': ['Rhesus D Genotype']}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the performance of Sequenom's noninvasive test for fetal RHD genotype. The test uses MALDI-TOF mass spectrometry to detect DNA. The study is specifically designed to determine whether RHD typing using free fetal DNA in maternal circulation can accurately predict the neonatal RhD phenotype at birth.", 'detailedDescription': 'In the United States and Canada, routine obstetrical care includes a blood test to determine the blood type of the mother (ABO and RhD). An antibody screen for anti-red cell antibodies in the mother\'s serum is also performed.\n\nPostpartum prophylactic treatment of RhD negative women with anti-D immunoglobulin to prevent "RhD Disease", or hemolytic disease of the fetus/newborn, was initiated in the 1960\'s. In the mid 1980\'s, the routine administration of antenatal anti-D immunoglobulin became the standard of care as well. Although these treatments have dramatically reduced the incidence of RhD Disease, approximately 40% of all RhD negative pregnancies continue to receive unnecessary injections of antenatal anti-D immunoglobulin.\n\nGenotyping platforms such as MALDI-TOF mass spectrometry allow for precise and sensitive detection of fetal-specific (paternally derived) alleles in maternal plasma. In this study, Sequenom\'s MassARRAY technology will be used to assess a noninvasive test for fetal RHD genotyping in a clinical setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who are known to be serologically RhD negative.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female at least 18 years of age\n* RhD negative by serology\n* Pregnant at no more than 11-13 weeks gestation confirmed by ultrasound\n* Willing to provide signed and dated informed consent\n* Able and willing to comply with the protocol\n\nExclusion Criteria:\n\n* RhD negative women known to be alloimmunized to the RhD antigen'}, 'identificationModule': {'nctId': 'NCT00871195', 'acronym': 'NAFTnet RHD', 'briefTitle': 'A Noninvasive Test for Fetal RHD Genotype', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sequenom, Inc.'}, 'officialTitle': 'Evaluation Of The Performance Of A Noninvasive Test For Fetal RHD Genotype On The Sequenom MassARRAY System', 'orgStudyIdInfo': {'id': 'SQNM-RHD-301'}}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Obstetrix Medical Group of Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45211', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Hospital', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt. Sinai School of Medicine', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Kenneth Moise, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sequenom, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NAFTNet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}