Vanishing TwinVANISHNCT05004337
Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies
An observational study of Vanishing Twin and Trisomy 21, run by Natera, Inc. at 21 sites in United States.
Trial summary
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vanishing Twin, Trisomy 21, Trisomy 13
- How many people
- 136 participants
- Where
- 21 sitesUnited States
- Study dates
- 22 Jul 2021to 29 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women carrying a vanishing twin pregnancy
Who may be able to join
- Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin
Who cannot join
- Monozygotic twin pregnancy
- Non twin pregnancy
- Maternal history of bone marrow or organ transplantation
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Cedar Health Research
Irving, Texas, 75039
University of Kansas
Kansas City, Kansas, 66160
Center for Fetal Medicine & Women's Ultrasound
Los Angeles, California, 90048
NYU Long Island
Mineola, New York, 11501
Hackensack
Neptune City, New Jersey, 07753
St. Peter's University Hospital
New Brunswick, New Jersey, 08901
Yale
New Haven, Connecticut, 06511
NYU Langone
New York, New York, 10022
Icahn School of Medicine at Mount Sinai Hospital
New York, New York, 10029
Columbia University
New York, New York, 10032
Weill Cornell Medicine
New York, New York, 10065
Christiana Care
Newark, Delaware, 19718
Stanford
Palo Alto, California, 94304
Emerald Coast ObGyn
Panama City, Florida, 32405
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Beaumont
Royal Oak, Michigan, 48073
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin
- Conditions
- Vanishing Twin, Trisomy 21, Trisomy 13, Trisomy 18
- Medical subject headings
- Down Syndrome, Trisomy 13 Syndrome, Trisomy 18 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a new algorithm and methodology that will measure fetal fraction and distinguish between the DT (demised/non-viable twin) and living twin (LT) in dizygotic twins (DZ) with a single LT.
A new algorithm will be written to analyze the serial research blood samples to return a fetal fraction of each twin, and identify which twin is the DT verses the LT. The fetal fraction measurement will be a percentage, and it will be measurable, or not measurable for each sample.
Measured: 2 years
The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.
Each complete participant in the study will have multiple maternal blood samples collected, and a child buccal swab. This outcome will use genetic analysis to reflect for each participant if the algorithm correctly or incorrectly identified the LT versus the DT. Accuracy, defined as the number of VT pairs correctly identified as the LT and DT, divided by the total number of VT pairs, will be calculated.
Measured: 2 Years
Secondary outcomes (1)
The accuracy of the updated algorithm for the assignment of risk for trisomy 21/18/13 for the LT in DZ twins with a single LT.
If a sufficient number of trisomy 21/18/13 cases are observed among any of the cases, assess the accuracy of the updated algorithm to correctly determine whether the LT or DT is aneuploidy. Point estimates and 95% confidence intervals for the specificity for the aneuploidy algorithm.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start22 Jul 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vanishing TwinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorraine Dugoff, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004337
- Sponsor's protocol ID
- 21-050-NPT
- Acronym
- VANISH
- Status last verified
- Sep 2024
- First submitted
- 28 Jul 2021
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dugoff L, Mumford SL, Rochon ML, Chavez M, Kohari K, Scholl JE, Berkin JA, Roman AS, Chueh J, Wolf SB, Palomares KTS, Hurt KJ, Wapner RJ, Gorman K, Wick MJ, Savasan ZA, Platt LD, Treadwell MC, Al-Khan A, Livingston JM, Hoffman MK, Rabin-Havt SS, Rabinowitz M, Ahmed E, Saben JL, Sun N, Butskova A, Xu W, Meltzer J, Souter V. Results from the VANISH study: A prospective multicenter study validating a single-nucleotide polymorphism-based noninvasive prenatal test to assess aneuploidy risk in surviving twins of vanishing twin pregnancies. Pregnancy (Hoboken). 2026 Oct 21;2(6):e70471. doi: 10.1002/pmf2.70471. eCollection 2026 Nov.
PubMed 42909945
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Risk Assignment for Whole Chromosome Using SNP-based NIPT in Vanishing Twin Pregnancies (VANISH)
- ClinicalTrials.gov ID
- NCT05004337
- Acronym / sponsor ID
- VANISH / 21-050-NPT
- Conditions
- Vanishing Twin, Trisomy 21, Trisomy 13, Trisomy 18
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect blood samples from women carrying a vanishing twin pregnancy to further develop Natera's non-invasive prenatal screening test to provide information about possible chromosomal conditions for the living twin
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women carrying a vanishing twin pregnancy
Key inclusion criteria (1 listed)
- Women with either ultrasound-documented dizygotic (DZ) twin pregnancy or those whose Panorama Test™ results suggest increased risk for vanishing twin
Key exclusion criteria (3 listed)
- Monozygotic twin pregnancy
- Non twin pregnancy
- Maternal history of bone marrow or organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a new algorithm and methodology that will measure fetal fraction and distinguish between the DT (demised/non-viable twin) and living twin (LT) in dizygotic twins (DZ) with a single LT.
Time frame: 2 years
A new algorithm will be written to analyze the serial research blood samples to return a fetal fraction of each twin, and identify which twin is the DT verses the LT. The fetal fraction measurement will be a percentage, and it will be measurable, or not measurable for each sample.
The accuracy of the new algorithm to determine which of the signals in the Panorama samples correspond to the LT versus the DT.
Time frame: 2 Years
Each complete participant in the study will have multiple maternal blood samples collected, and a child buccal swab. This outcome will use genetic analysis to reflect for each participant if the algorithm correctly or incorrectly identified the LT versus the DT. Accuracy, defined as the number of VT pairs correctly identified as the LT and DT, divided by the total number of VT pairs, will be calculated.
1 secondary outcome
The accuracy of the updated algorithm for the assignment of risk for trisomy 21/18/13 for the LT in DZ twins with a single LT.
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 42909945Dugoff L, Mumford SL, Rochon ML, Chavez M, Kohari K, Scholl JE, Berkin JA, Roman AS, Chueh J, Wolf SB, Palomares KTS, Hurt KJ, Wapner RJ, Gorman K, Wick MJ, Savasan ZA, Platt LD, Treadwell MC, Al-Khan A, Livingston JM, Hoffman MK, Rabin-Havt SS, Rabinowitz M, Ahmed E, Saben JL, Sun N, Butskova A, Xu W, Meltzer J, Souter V. Results from the VANISH study: A prospective multicenter study validating a single-nucleotide polymorphism-based noninvasive prenatal test to assess aneuploidy risk in surviving twins of vanishing twin pregnancies. Pregnancy (Hoboken). 2026 Oct 21;2(6):e70471. doi: 10.1002/pmf2.70471. eCollection 2026 Nov.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine Dugoff, MD principal investigator
University of Pennsylvania
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vanishing Twin and Trisomy 21, run by Natera, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a new algorithm and methodology that will measure fetal fraction and distinguish between the DT (demised/non-viable twin) and living twin (LT) in dizygotic twins (DZ) with a single LT. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05004337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.