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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Blood sample for Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including

Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma. Its presence in maternal plasma has allowed development of noninvasive prenatal diagnosis for single-gene disorders (SGD-NIPD).

Official registry: https://clinicaltrials.gov/study/NCT06147414 · Assistance Publique - Hôpitaux de Paris · enrollment listed as 550

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 550 people at Paris. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

Evaluation of the Diagnostic Performance of Non-Invasive Prenatal Diagnosis for Single Gene Disorders

Interventions: Blood sample

Primary outcome (registry wording): % of affected/unaffected fetuses that were correctly classified as affected/unaffected

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Women only
  • pregnant woman with 9 weeks of amenorrhea or more
  • singleton pregnancy
  • undergoing invasive PND in a context of family history of SGD involving the following genes : HBB, CFTR, FMR1, SMN1, DMPK, DMD, NF1, HTT, F8, F9, GCK, L1CAM, PKHD1, or undergoing prenatal counselling in a context of maternal history of diabetes MODY-GCK
  • germinal pathogenic paternal and/or maternal mutations previously identified
  • age 18 years old or over

Public study contact (from the registry)

Juliette NECTOUX, MD,PhD

01 58 41 11 86

juliette.nectoux@aphp.fr

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06147414 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06147414?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06147414?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary