- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01426308
Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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South Carolina
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Charleston, South Carolina, Forente stater, 29403
- Medical University of South Carolina
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Texas
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Houston, Texas, Forente stater, 77021
- Baylor College of Medicine
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Utah
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Salt Lake City, Utah, Forente stater, 84108
- ARUP Laboratories
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
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Method Comparison Group
The method comparison group will consist of de-identified, leftover DNA samples from patients referred for post-natal cytogenetic testing.
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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.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Cyto-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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