Post-natal CytogeneticsNCT01426308
Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test
An observational study of Post-natal Cytogenetics, run by Illumina, Inc. at 3 sites in United States.
Trial summary
The study will determine the performance of the Infinium HD Test. The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population. Read more about this study
- Who is it for?
- Ages 1 minute and olderHealthy volunteers can take part
- Conditions the study is for
- Post-natal Cytogenetics
- How many people
- 900 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2011to Nov 2011
- 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 1 minute and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Leftover, de-identified DNA extracted from EDTA or heparin anticoagulated whole blood samples.
Method Comparison - Sample Inclusion Criteria
The following are criteria for inclusion of extracted genomic DNA samples in the method comparison sample pool:
- Sample is from a patient referred for post-natal cytogenetic testing.
- Sample gender is known.
- Sample quantity available for testing is ≥ 1 microgram of genomic DNA at a concentration of 60-80 nanograms per microliter (60-80ng/µl).
- Sample is extracted genomic DNA from EDTA or heparin-anticoagulated whole blood.
- Sample has been stored at 2 to 8°C or -15 to -25°C for no greater than three years from the date of extraction.
- Sample has been tested by a reference method. Acceptable reference methods include karyotype, FISH, qPCR, MLPA, and methylation analysis.
Method Comparison - Sample Exclusion Criteria
- Sample is from a patient not referred for post-natal cytogenetic testing.
- Sample is from a patient referred for cytogenetic oncology testing.
- Sample quantity < 1 microgram of genomic DNA or less than 60 nanograms per microliter (60ng/µl).
- Sample was improperly stored or was extracted from a sample that was improperly stored.
- Sample was tested by an Illumina array during standard of care testing.
Clinical Specificity - Sample Inclusion Criteria
The following are criteria for inclusion of extracted genomic DNA samples in the clinical specificity sample pool:
- Sample gender is known.
- Sample is from a patient not referred for post-natal cytogenetic testing.
- Sample quantity available for testing is ≥ 1 microgram of genomic DNA at a concentration of at least 60-80 nanograms per microliter (60-80ng/µl).
- Sample is extracted genomic DNA from EDTA or heparin-anticoagulated whole blood.
- Sample has been stored at 2 to 8°C or -15 to -25°C for no greater than three years from the date of extraction.
Clinical Specificity - Sample Exclusion Criteria
- Sample is from a patient referred for post-natal cytogenetic testing.
- Sample quantity < 1 microgram of genomic DNA or less than 60 nanograms per microliter (60ng/µl).
- Sample was improperly stored or was extracted from a sample that was improperly stored.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29403
Baylor College of Medicine
Houston, Texas, 77021
ARUP Laboratories
Salt Lake City, Utah, 84108
About this study
The study will determine the performance of the Infinium HD Test.
- The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population.
- The secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the Infinium HD Test.
- Conditions
- Post-natal Cytogenetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Method Comparison Group | The method comparison group will consist of de-identified, leftover DNA samples from patients referred for post-natal cytogenetic testing. | |
| Clinical Specificity Group | The clinical specificity group will consist of de-identified, leftover DNA samples from non-phenotypic patients, or patients not referred for post-natal cytogenetic testing. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-natal CytogeneticsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illumina, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426308
- Sponsor's protocol ID
- Cyto-001
- Status last verified
- Sep 2011
- First submitted
- 29 Aug 2011
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test
- ClinicalTrials.gov ID
- NCT01426308
- Acronym / sponsor ID
- Cyto-001
- Conditions
- Post-natal Cytogenetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Illumina, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Aug 2011 (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 study will determine the performance of the Infinium HD Test.
- The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population.
- The secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the Infinium HD Test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method Comparison Group | – | –The method comparison group will consist of de-identified, leftover DNA samples from patients referred for post-natal cytogenetic testing. |
| Clinical Specificity Group | – | –The clinical specificity group will consist of de-identified, leftover DNA samples from non-phenotypic patients, or patients not referred for post-natal cytogenetic testing. |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Leftover, de-identified DNA extracted from EDTA or heparin anticoagulated whole blood samples.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-natal Cytogenetics, run by Illumina, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 Apr 2016.