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Genetic Testing

Identifai Genetics Analytic Validity - Compound Heterozygosity and Samples Collection for Prenatal Diagnosis

Q: Are researchers currently seeking participants for this study?

<p>As per clinicaltrials.gov, this current medical investigation is actively pursuing participants. The trial was initially published on December 5th, 2023 and last revised on January 31st, 2024.</p>

Q: What is the current number of individuals receiving medical care as part of this clinical trial?

<p>Affirmative. Information from clinicaltrials.gov states that this research initiative is presently seeking participants. The trial was initially disclosed on December 5th, 2023, and the most recent modification occurred on January 31st, 2024. Recruitment aims to enroll a total of one hundred individuals across a single site.</p>

N/A

Recruiting

Research Sponsored by Identifai Genetics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parental age ≥18

Parents are both carriers of different known pathogenic SNVs or short indels (<=5bp) in the same gene (compound heterozygosity)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

Study Summary

This trial aims to confirm a new way to diagnose genetic conditions in unborn babies by testing the baby's genetic material found in the mother's blood.

Who is the study for?

This trial is for pregnant individuals who are interested in a noninvasive prenatal diagnosis to check for genetic conditions in their developing fetus. The study involves analyzing fetal DNA found in the mother's blood.Check my eligibility

What is being tested?

The study is testing the accuracy of a new Non Invasive Prenatal Test (NIPT) that uses a blood sample from the pregnant individual to detect potential genetic issues in the fetus without any riskier invasive procedures.See study design

What are the potential side effects?

Since this test only requires drawing blood, similar to routine blood tests during pregnancy, side effects are minimal and may include slight pain or bruising at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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Both my parents carry different known genetic mutations in the same gene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analytic Validity - Sensitivity

Analytic Validity - Specificity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Identifai Genetics Analytic Validity - Compound Heterozygosity and Samples CollectionExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Identifai GeneticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this study?

"As per clinicaltrials.gov, this current medical investigation is actively pursuing participants. The trial was initially published on December 5th, 2023 and last revised on January 31st, 2024."

Answered by AI

What is the current number of individuals receiving medical care as part of this clinical trial?

"Affirmative. Information from clinicaltrials.gov states that this research initiative is presently seeking participants. The trial was initially disclosed on December 5th, 2023, and the most recent modification occurred on January 31st, 2024. Recruitment aims to enroll a total of one hundred individuals across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Identifai Genetics Analytic Validity Study - Compound Heterozygosity and Samples Collection

2023. "Identifai Genetics Analytic Validity Study - Compound Heterozygosity and Samples Collection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06239077.