Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-01 @ 6:28 AM
Study NCT ID:
NCT03629795
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sample handling', 'timeFrame': '3 months', 'description': 'Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trisomy 21 in Fetus', 'Trisomy 18 in Fetus', 'Trisomy 13 in Fetus']}, 'descriptionModule': {'briefSummary': "Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.", 'detailedDescription': "Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.\n\nBlood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'First trimester pregnancy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:\n\n 1. Subject is ≥ 18 years of age\n 2. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.\n 3. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm\n\nExclusion Criteria:\n\n* A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:\n\n 1. Subject is unable to give consent\n 2. Subject has already participated in the study'}, 'identificationModule': {'nctId': 'NCT03629795', 'briefTitle': 'Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axis Shield Diagnostics Ltd'}, 'officialTitle': 'Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA CENTAUR® PREGNANCY ASSOCIATED PLASMA PROTEIN A and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin ASSAYS', 'orgStudyIdInfo': {'id': 'TO06'}}, 'contactsLocationsModule': {'locations': [{'zip': 'NE24HH', 'city': 'Newcastle upon Tyne', 'state': 'UK', 'country': 'United Kingdom', 'facility': 'Newcastle University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Stephen Robson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Fetal Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axis Shield Diagnostics Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Clinical Trial Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}