NCT00314691

Brief Summary

After extraction of the cell-free DNA circulating in maternal plasma, we aim at developing new techniques for fetal DNA enrichment to perform fetal gender determination, and indirect diagnosis of inherited diseases like Cystic Fibrosis, Huntington Disease, Myotonic Dystrophy, B-Thalassaemia...

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2007

First QC Date

April 12, 2006

Last Update Submit

July 27, 2011

Conditions

Hereditary Diseases

Keywords

fetal DNAprenatal diagnosismaternal plasmaDiagnostic potential of cell-free fetal DNA circulating in maternal blood

Outcome Measures

Primary Outcomes (1)

  • Feasibility of fetal gender and genotype determination out of maternal blood

Interventions

Blood samplesGENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mother and father-to-be both older than 18 years old
  • Mother and father-to-be affiliated to social security
  • Mother and father-to-be have good understanding of the protocol
  • Pregnancy of the mother-to-be attested

You may not qualify if:

  • Mother and father-to-be are younger than 18 years old
  • Mother and/or father-to be refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sihcus-Cmco

Strasbourg, Schiltigheim, 67300, France

Location

MeSH Terms

Conditions

Genetic Diseases, Inborn

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Romain FAVRE, MD

    SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 14, 2006

Study Start

April 1, 2006

Study Completion

September 1, 2006

Last Updated

July 28, 2011

Record last verified: 2007-07

Locations

FR(1)