Hereditary DiseasesNCT00314691
Development of New Prenatal Diagnostic Tests From Maternal Blood
A study testing Blood samples in people with Hereditary Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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... Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Diseases
- What is being tested?
- Blood samples
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mother and father-to-be are younger than 18 years old
- Mother and/or father-to be refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
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...
- Conditions
- Hereditary Diseases
- Being tested
- Blood samples
- Keywords
- fetal DNA, prenatal diagnosis, maternal plasma, Diagnostic potential of cell-free fetal DNA circulating in maternal blood
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of fetal gender and genotype determination out of maternal blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startApr 2006
- Study completionSep 2006
Why it stopped: Leaving of the person responsible for the data collection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Romain FAVRE, MD, Principal investigator, SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314691
- Sponsor's protocol ID
- 3612
- Status last verified
- Jul 2007
- First submitted
- 12 Apr 2006
- Last updated
- 28 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Prenatal Diagnostic Tests From Maternal Blood
- ClinicalTrials.gov ID
- NCT00314691
- Acronym / sponsor ID
- 3612
- Conditions
- Hereditary Diseases
- Keywords
- fetal DNA, prenatal diagnosis, maternal plasma, Diagnostic potential of cell-free fetal DNA circulating in maternal blood
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Leaving of the person responsible for the data collection
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Sep 2006
- First posted
- 14 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Mother and father-to-be are younger than 18 years old
- Mother and/or father-to be refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples | Genetic | – |
Primary outcome
Feasibility of fetal gender and genotype determination out of maternal blood
Results and safety
The study was stopped early (reason given: Leaving of the person responsible for the data collection). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain FAVRE, MD principal investigator
SIHCUS-CMCO de Schiltigheim, Strasbourg, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Hereditary Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Leaving of the person responsible for the data collection). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of fetal gender and genotype determination out of maternal blood. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.