Cell-free DNA Analysis of Chromosome Anomalies in Early P... | NCT04935138

Studies
Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

NCT04935138

Sponsor

Quest Diagnostics-Nichols Insitute

Status

Terminated

Last Update Posted

Dec 1, 2023Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Early Pregnancy Loss

Interventions

cfDNA analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low participation

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2023

Last Update Posted Date

Dec 1, 2023Actual

Name	Class
Illumina, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

78Actual

Name	Type	Description	Arm Group Labels	Other Names
cfDNA analysis	Genetic	sequencing data from cfDNA analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microarray analysis of products of conception (POC)	chromosome anomalies	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

5-20 weeks of gestation by ultrasound
Miscarriage diagnosed by ultrasound
Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

Exclusion Criteria:

Maternal age < 18 years
No visible pregnancy tissue on ultrasound
Multiple fetal gestation (> than singleton)
Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
No microarray testing is planned on the product of conception
Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
Patient unable to provide consent

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Previously pregnant women that have recently miscarried.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pranoot X Tanpaiboon, MD	Quest Diagnostics-Nichols Insitute	Principal Investigator
Karen E Racicot, PhD	Quest Diagnostics-Nichols Insitute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quest Diagnostics		San Juan Capistrano	California	92675	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22835448	Background	Practice Committee of the American Society for Reproductive Medicine. Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2012 Nov;98(5):1103-11. doi: 10.1016/j.fertnstert.2012.06.048. Epub 2012 Jul 24.
8737980	Background	Barisic I, Zergollern L, Muzinic D, Hitrec V. Risk estimates for balanced reciprocal translocation carriers--prenatal diagnosis experience. Clin Genet. 1996 Mar;49(3):145-51. doi: 10.1111/j.1399-0004.1996.tb03274.x.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases