Fetal Genome Profiling Via Trophoblast Cells

NCT03832634 | Terminated

• 1 other identifier: 1703018076
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to utilize trophoblast cells accumulating in the endocervical canal at the beginning of pregnancy for non-invasive prenatal testing. If we are able to validate that trophoblast cells obtained at an early gestational age can be reliably used for prenatal testing, there is great potential to improve early pregnancy management and counseling options for potential parents. The target population will be all women between the age of 18-45 undergoing care at the Center for Reproductive Medicine (CRM) in order to achieve a pregnancy.

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

• Occurrence of chromosomal anomalies as detected via fetal genome analysis of trophoblast cells

  Trophoblast cells isolated from the cervix will be used to detect chromosomal anomalies occurrences as a means of non-invasive prenatal screening.

  6 weeks post pregnancy

Secondary Outcomes (1)

• Occurrence of chromosomal anomalies detected via trophoblast cell analysis as compared to occurrence of chromosomal anomalies detected via preimplantation genetic testing (PGT), chorionic villi sampling (CVS), amniocentesis, or cytogenetic results.

  16 weeks post pregnancy

Study Arms (1)

Fetal Genome Profiling

OTHER

Trophoblast cells will be collected from the cervix approximately 5-6 weeks once pregnancy is achieved.

Diagnostic Test: Fetal Genome Profiling.

Interventions

Fetal Genome Profiling. DIAGNOSTIC_TEST

Once pregnancy is achieved, patients will undergo non-invasive collection of trophoblast cells (trophoblast retrieval and isolation from the cervix, TRIC) at an early gestational age, approximately 5-6 weeks. The patient will also be screened with blood work for carrier status for genetic conditions.

Fetal Genome Profiling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 to 45 who achieve a pregnancy during study time period.
• If pregnancy result in miscarriage, cytogenetic testing must be completed on the product of conception.

You may not qualify if:

• Women whose cervical sample collection containing inadequate number of trophoblast cells for analysis.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kangpu Xu, PhD, DVM

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: February 6, 2019
• Study Start: July 2, 2020
• Primary Completion: February 14, 2021
• Study Completion: February 2, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)