Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Utility of Aberrant Gene Methylation in the Diagnosis of Barrett's Esophagus: Identification of Candidate Diagnostic Markers
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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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:
Controls: No endoscopic evidence of Barrett's Esophagus, able to give informed consent, 18 years of age or older.
Cases: At least 1 cm of visible columnar epithelium with intestinal metaplasia on histology confirmed by an expert GI pathologist (on biopsy), able to give informed consent, 18 years of age or older.
Exclusion criteria:
Controls: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), varices, esophagitis LA Grade B, C, D will be excluded. Patients with prior history of colon polyps or colon/esophageal/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).
Cases: Patients with history of esophagectomy or mucosal ablation, gastrectomy, or known non-Barrett's esophageal pathology (e.g. eosinophilic esophagitis or achalasia), will be excluded. Patients with prior history of colon polyps or colon/gastric/pancreatic carcinoma (unless had negative colonoscopy within 2 years to clear polyps).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Endoscopy Barrett's
Patients undergoing clinically indicated upper endoscopy will be invited to participate.
Patients who are known to have Barrett's Esophagus as well as patient who do not will be approached for enrollment
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Endoscopy control
Patients undergoing clinically indicated upper endoscopy will be invited to participate.
Patients who are known to have Barrett's Esophagus as well as patient who do not will be approached for enrollment
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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to determine if assay of aberrantly methylated gene markers can discriminate Barrett's Esophagus tissue (and presence of dysplasia) from esophageal squamous and gastric cardia tissue.
Tidsramme: 1 day
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we will plan to identify the best markers from highly selected marker candidates to differentiate between subjects who have BE and those who do not have BE.
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1 day
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus
Tidsramme: One day
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Assess the ability of stool markers to distinguish between subjects who have BE and those who do not.
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One day
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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 (Faktiske)
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
- 12-001575
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