15 completed, 4 unknown, 2 recruiting, 2 terminated. 4 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 4 | Completed 2, Enrolling by invitation 1, Recruiting 1 |
Follow Trisomy 13 Syndrome: new trials by email Literature Review of Trisomy 13 Syndrome trials Research Report on Trisomy 13 Syndrome
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment Pregnant Individuals, Aneuploidy | Recruiting | BillionToOne Inc. | 1000 | 2026-01-10 | 2026-10-15 | |
| Palliative Care Needs of Children With Rare Diseases and Their Families Family Centered pediatric palliative care for family caregivers of children with rare diseases. - Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia | Not applicable | Enrolling by invitation | Children's National Research Institute | 480 | 2025-10-02 | 2026-01-28 |
| Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities 40-Minute Real-Time First-Trimester Ultrasonography - Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy | Active not recruiting | Haseki Training and Research Hospital | 270 | 2025-08-28 | 2025-09-10 | |
| Physical Activity and Community EmPOWERment Project PACE Program - Intellectual Disability, Neurodevelopmental Disorders | Not applicable | Recruiting | University of North Carolina, Chapel Hill | 376 | 2025-01-10 | 2026-02-23 |
| Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies Vanishing Twin, Trisomy 21 | Completed | Natera, Inc. | 136 | 2021-07-22 | 2026-08-17 | |
| Feasibility Study of a New Screening Program for Major Aneuploidies (T21, T18, T13) in the Emilia-Romagna Region (SAPERER) NIPT - Autosomal Aneuploidy | Unknown | Azienda Usl di Bologna | 7000 | 2020-01-27 | 2020-07-24 | |
| Study of Vanadis® NIPT for Non-invasive Prenatal Screening of Trisomies (T21, T18 and T13) Vanadis NIPT system - Trisomy 21, Trisomy 18 | Unknown | PerkinElmer, Wallac Oy | 1200 | 2018-06-20 | 2018-08-29 | |
| VAlidation of a Lower Cost aneUploidy scrEen SmartNIPT - Down Syndrome, Trisomy 18 | Completed | Women and Infants Hospital of Rhode Island | 2443 | 2017-10-10 | 2022-09-22 | |
| Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies Blood sample - Down Syndrome, Patau Syndrome | Not applicable | Completed | Premaitha Health | 1000 | 2016-02-01 | 2020-06-11 |
| Expanded Noninvasive Genomic Medical Assessment: The Enigma Study Blood sampling for Laboratory Developed Test (LDT) analysis - Down Syndrome, Edwards Syndrome | Completed | Progenity, Inc. | 760 | 2015-10-01 | 2019-08-21 | |
| SNP-based Microdeletion and Aneuploidy RegisTry (SMART) 22q11 Deletion Syndrome, DiGeorge Syndrome | Completed | Natera, Inc. | 20960 | 2015-04-01 | 2021-01-29 | |
| Whole Blood Specimen Collection From Pregnant Subjects Observational - no intervention - Down Syndrome, Edwards Syndrome | Unknown | Progenity, Inc. | 5000 | 2015-03-01 | 2020-09-17 | |
| Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies Down Syndrome, Edwards Syndrome | Terminated | Sequenom, Inc. | 50 | 2014-08-01 | 2015-09-17 | |
| High Risk Multiple Gestation Study Trisomy 13, Trisomy 18 | Completed | Natera, Inc. | 99 | 2014-08-01 | 2019-06-13 | |
| Prenatal Screening for Down Syndrome With DNAFirst Trisomy 21, Trisomy 18 | Completed | Women and Infants Hospital of Rhode Island | 100 | 2014-06-01 | 2018-02-22 | |
| Non-Invasive Chromosomal Evaluation of Trisomy Study Aneuploidy, Trisomy 21 | Completed | Cindy Cisneros | 2000 | 2014-04-01 | 2020-04-30 | |
| Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood Integrated prenatal screening for Down's syndrome, Serum QUAD Assay for aneuploidy screening, Semiconductor MPSS NIPT assay using ccfDNA in maternal blood - Trisomy 21, Trisomy 18 | Not applicable | Completed | CHU de Quebec-Universite Laval | 3819 | 2013-11-01 | 2018-02-22 |
| Multiple Gestation Study Trisomy 13, Trisomy 18 | Completed | Natera, Inc. | 354 | 2013-03-01 | 2019-08-26 | |
| Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood Trisomy 21, Trisomy 18 | Completed | Natera, Inc. | 1059 | 2012-11-01 | 2020-12-30 | |
| Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA Microdeletion Syndromes, Trisomy 21 | Completed | Natera, Inc. | 216 | 2012-10-01 | 2019-08-26 |
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Down Syndrome (24) · Trisomy 18 Syndrome (23) · Turner Syndrome (12) · Sex Chromosome Aberrations (7) · Aneuploidy (6) · DiGeorge Syndrome (4) · Klinefelter Syndrome (4) · Cri-du-Chat Syndrome (2) · Prader-Willi Syndrome (2) · Trisomy (2) · 22q11 Deletion Syndrome (1) · Angelman Syndrome (1) · Anxiety Disorders (1) · Autism Spectrum Disorder (1)
Abnormalities, Multiple (25) · Cardiovascular Abnormalities (25) · Cardiovascular Diseases (25) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (25) · Genetic Diseases, Inborn (25) · Heart Defects, Congenital (25) · Heart Diseases (25) · Nervous System Diseases (25) · Neurobehavioral Manifestations (25) · Neurologic Manifestations (25) · Chromosome Disorders (24) · Congenital Abnormalities (24) · Intellectual Disability (24) · Endocrine System Diseases (15) · Disorders of Sex Development (14)
Blood Specimen Collection (4) · Telbivudine (1) · dichlorobis(azomycin)platinum II (1)
Natera, Inc. (8) · Progenity, Inc. (2) · Sequenom, Inc. (2) · Women and Infants Hospital of Rhode Island (2) · Azienda Usl di Bologna (1) · BillionToOne Inc. (1) · CHU de Quebec-Universite Laval (1) · Children's National Research Institute (1) · Cindy Cisneros (1) · Haseki Training and Research Hospital (1) · Lenetix Medical Screening Laboratory (1) · PerkinElmer, Wallac Oy (1) · Premaitha Health (1) · University of North Carolina, Chapel Hill (1) · Verinata Health, Inc. (1)
United States (20) · Italy (4) · Canada (3) · Spain (3) · Ireland (2) · United Kingdom (2) · Australia (1) · India (1) · Malaysia (1) · South Korea (1) · Sweden (1) · Taiwan (1) · Turkey (Türkiye) (1)
Glenn E Palomaki, PhD (2) · Peer Dar, MD (2) · Allan Bombard, MD (1) · Amy J Sehnert, MD (1) · Asma Khalil, MBBS (1) · Brian Kirshon, MD (1) · Brianne R Tomaszewski, PhD., MPH (1) · Enza Pavanello (1) · Errol Norwitz, MD, PhD (1) · Francois Rousseau, MD MSc FRCPC (1) · Joanne Stone, MD (1) · Julia Wynn, MS, MS, CGC (1) · Kim Martin, MD (1) · Lorraine Dugoff, MD (1) · Mary Norton, MD (1)
PMID 10417280, PMID 12820840, PMID 16814942, PMID 20375405, PMID 21310373, PMID 21519036, PMID 22005709, PMID 22281937, PMID 22464072, PMID 22617594, PMID 22742782, PMID 23215555, PMID 23613152, PMID 23712453, PMID 24135152, PMID 24388429, PMID 24571752, PMID 24785862, PMID 25004354, PMID 25111587, PMID 25479548, PMID 25834952, PMID 28079901, PMID 31231136, PMID 34492029, PMID 34761647, PMID 35033576, PMID 35085538, PMID 35136187, PMID 36103259, PMID 36965866, PMID 41775005, PMID 9647154
R01AG076678 (1), R01HD117137 (1), R44HD062114 (1)