Genetic DisordersNCT00214448
Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples
An observational study of Genetic Disorders, run by Abbott Molecular.
Trial summary
The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Genetic Disorders
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be able to donate at least 10 mL of whole blood
- Must be able to provide consent, or parental consent and patient assent (if applicable)
- Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
- Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions)
Who cannot join
- Unable to donate at least 10 mL of whole blood
- Unable to provide consent, or parental consent and patient assent (if applicable)
- Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
- Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples
The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.
- Conditions
- Genetic Disorders
- Keywords
- Multiple genetic conditions will be studied
- Medical subject headings
- Genetic Diseases, Inborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic DisordersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 4 participants
Sponsor and investigators
- Lead sponsor
- Abbott Molecular
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214448
- Sponsor's protocol ID
- 05-801
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 14 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples
- ClinicalTrials.gov ID
- NCT00214448
- Acronym / sponsor ID
- 05-801
- Conditions
- Genetic Disorders
- Keywords
- Multiple genetic conditions will be studied
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants
- Lead sponsor
- Abbott MolecularIndustry (pharma, biotech, devices)
- First posted
- 22 Sep 2005 (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.
The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Must be able to donate at least 10 mL of whole blood
- Must be able to provide consent, or parental consent and patient assent (if applicable)
- Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
- Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions)
Key exclusion criteria (4 listed)
- Unable to donate at least 10 mL of whole blood
- Unable to provide consent, or parental consent and patient assent (if applicable)
- Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
- Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2006.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Disorders, run by Abbott Molecular.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynda Hague (224-361-7101, lynda.hague@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 14 Jul 2006.