Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-09 @ 7:22 AM
Study NCT ID:
NCT02808494
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stored for future assay development use.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2016-04-26', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cfRNA markers associated with preeclampsia with severe features and/or fetal growth restrictions', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preeclampsia', 'Fetal Growth Restriction'], 'conditions': ['Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '32611681', 'type': 'RESULT', 'citation': "Munchel S, Rohrback S, Randise-Hinchliff C, Kinnings S, Deshmukh S, Alla N, Tan C, Kia A, Greene G, Leety L, Rhoa M, Yeats S, Saul M, Chou J, Bianco K, O'Shea K, Bujold E, Norwitz E, Wapner R, Saade G, Kaper F. Circulating transcripts in maternal blood reflect a molecular signature of early-onset preeclampsia. Sci Transl Med. 2020 Jul 1;12(550):eaaz0131. doi: 10.1126/scitranslmed.aaz0131."}]}, 'descriptionModule': {'briefSummary': 'Sample Collection Study', 'detailedDescription': 'This is a limited prospective collection of whole blood samples from pregnant women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction in addition to samples from a control group to aid in the development of a Next Generation Sequencing (NGS)-based assay to detect molecular markers associated with preterm preeclampsia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Affected Group: Pregnant women diagnosed with preeclampsia with severe features or fetal growth restriction\n\nControl group: Pregnant women matched for gestational age to the Affected group above', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women 18 years of age or older at enrollment\n2. Pregnant women with a viable singleton gestation\n3. Able to provide written, informed consent\n4. Able to provide 20 mL of whole blood\n5. Diagnosis of preeclampsia with severe features and/or diagnosis of fetal growth restriction.\n\n 1. Preeclampsia with severe features is defined as:\n\n Proteinuria: Excretion of ≥300mg/24hr (24 hour collection) of protein or a timed excretion that is extrapolated to the 24 hour urine value or a protein/creatinine \\[both in mg/dL\\] ratio of at least 0.3 or a qualitative determination of (urine dipstick) of ≥1+ WITH Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on at least 2 occasions 4 hours apart while on bedrest but before the onset of labor OR Systolic BP ≥160mmHg or diastolic BP ≥110mmHg on 1 occasion but before the onset of labor, if antihypertensive therapy is initiated due to severe hypertension OR New onset hypertension defined as: Systolic BP ≥140 mmHg or diastolic ≥90 mmHg with one or more of the following features: Thrombocytopenia (\\<100,000 plts/mL); impaired liver function (AST/ALT 2X ULN); newly developed renal insufficiency (serum creatinine \\>1.1mg/dL or a doubling of serum creatinine in the absence of other renal disease); pulmonary edema; new onset cerebral disturbances or scotomata\n 2. Fetal Growth Restriction defined as:\n\n Estimated fetal weight by ultrasound at ≥ 19 0/7 weeks gestational age \\< 5%ile or 5-10%ile with abnormal umbilical artery Doppler examination (S/D ratio \\>95%ile for gestational age, absent end diastolic flow or reverse end diastolic flow)\n6. Gestational age between 20 0/7 and 33 6/7 weeks determined by ultrasound and/or LMP per ACOG guidelines1. A subject diagnosed with preeclampsia without severe features prior to 33 6/7 weeks gestation and who is managed expectantly and develops severe features after 34 weeks may be included.\n\nExclusion Criteria:\n\n1. Known malignancy\n2. History of maternal organ or bone marrow transplant\n3. Maternal blood transfusion in the last 8 weeks\n4. Chronic hypertension diagnosed prior to current pregnancy\n5. Type I, II or gestational diabetes\n6. Fetal anomaly or known chromosome abnormality\n7. Active labor'}, 'identificationModule': {'nctId': 'NCT02808494', 'briefTitle': 'Development of a Next Generation Sequencing (NGS) -Based Assay to Detect Preeclampsia Molecular Markers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Illumina, Inc.'}, 'officialTitle': 'Prospective Collection of Whole Blood Specimens of Subjects Diagnosed With Preeclampsia With Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development', 'orgStudyIdInfo': {'id': 'RGH-014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Affected Group', 'description': 'Women with a diagnosis of preeclampsia with severe features and/or fetal growth restriction.'}, {'label': 'Control/Unaffected Group', 'description': 'Women who do not have a diagnosis of preeclampsia with severe features and/or fetal growth restriction.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Peter's University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}, {'zip': '08080', 'city': 'Sewell', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Virtua Materna-Fetal Medicine Specialists', 'geoPoint': {'lat': 39.7665, 'lon': -75.14434}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian/Queens', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian/Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11501', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital Clinical Trials Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Matthew Rhoa, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Illumina, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Illumina, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}