- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00696345
Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay
Feasibility Study for Performance of Septin 9 in Plasma From Cases With Colorectal Cancer and Controls With Non-Diseased, Non-Colorectal Disease and Non-Colorectal Cancers
Studieoversikt
Status
Forhold
Detaljert beskrivelse
From public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of CRC screening initiatives; as stated by Sidney Winawer, MD, "the best test is the one that gets done." Current CRC screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 16% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for CRC detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.
Epigenomics has identified methylated gene regions that are specific for colorectal cancer or pre-malignant tissue. Aberrantly methylated genes represent attractive candidate markers for cancer screening, as cancer-specific methylation changes occur early in tumorigenesis, appear to be stable, yield a positive amplifiable signal, and can be assayed with high analytical sensitivity. Since methylation occurs early and in distinct genomic areas, it is possible to achieve high clinical sensitivity with a small number of methylated DNA markers. Studies have shown that aberrantly methylated DNA markers can be detected in tissue and body fluids and are highly correlated to colorectal cancer.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Berlin, Tyskland
- Department of Surgery and Surgical Oncology, Charité Campus Berlin Buch
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Dresden, Tyskland, 01307
- Department of Visceral-, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus
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Lübeck, Tyskland, 23538
- Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck
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Völklingen, Tyskland
- Völklingen Clinic
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Budapest, Ungarn
- Semmelweis University
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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
Inclusion Criteria:
- Group 1 diagnosis of colorectal cancer
Exclusion Criteria:
- Group 2 diagnosis of colorectal cancer
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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1
Colorectal cancer patients, Stages I-IV
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2
Non colorectal cancer patients, verified by colonoscopy
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Catherine Lofton-Day, PhD, Epigenomics, Inc
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Septin-9-2006
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