RECRUITING

Identifai Genetics Analytic Validity Study - Compound Heterozygosity and Samples Collection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to validate a noninvasive prenatal diagnosis procedure for genetic conditions in the developing fetus by analyzing fetal genetic material present in the pregnant mother's blood.

Official Title

Identifai Genetics Analytical Validation Study

Quick Facts

Study Start:2023-12-05
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06239077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parental age≥18
  2. * Singleton pregnancy
  3. * Willingness and ability to provide informed consent to participate in study
  4. * Patient having a diagnostic procedure (CVS, amniocentesis, cordocentesis) or delivering on site (obtain cord blood/cord segment)
  5. * Gestational age: 10-23 weeks
  6. * Parents are both carriers of different known pathogenic SNVs or short indels (\<=5bp) in the same gene (compound heterozygosity).
  7. * Gestational age ≥10 weeks
  8. * Either parent or both carry a known structural variant and/or other chromosomal anomalies AND/OR Ultrasound highly suggestive of an underlying genetic aberration (e.g., cardiac outlet and 22q)
  1. * Any Multiple gestation is excluded (MCDA, DCDA, triplets, etc)

Contacts and Locations

Study Contact

Gilad Magnazi, MEng, MBA
CONTACT
+972547627177
giladm@identifai-genetics.com
Noa Liscovitz Brauer, PhD
CONTACT
+972507945524
noal@identifai-genetics.com

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10027
United States

Collaborators and Investigators

Sponsor: Identifai Genetics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • NIPS
  • NIPT

Additional Relevant MeSH Terms

  • Prenatal Diagnosis
  • Genetics