- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02066701
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
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assess the accuracy of candidate markers in stool for detection of Barrett's Esophagus
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-001575
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Kliniska prövningar på Barretts matstrupe
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Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedAvslutadBarretts matstrupe | Höggradig dysplasi i Barrett Esophagus | Låggradig dysplasi i Barrett EsophagusFörenta staterna
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University Medical Center GroningenAvslutadMatstrupscancer | Barrett Esophagus | Dysplasi i Barrett EsophagusNederländerna
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International Agency for Research on CancerUniversity of Cambridge; Kilimanjaro Clinical Research InstituteAvslutad
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Nantes University HospitalRekryteringBarrett EsophagusFrankrike
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Columbia UniversityNational Cancer Institute (NCI); University of MichiganRekrytering
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Professor Michael BourkeRekryteringBarretts matstrupeAustralien
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Dallas VA Medical CenterAvslutad
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Massachusetts General HospitalNational Cancer Institute (NCI)AvslutadBarretts matstrupeFörenta staterna
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Massachusetts General HospitalNational Cancer Institute (NCI); National Institutes of Health (NIH)Aktiv, inte rekryterandeBarretts matstrupeFörenta staterna
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University of MichiganAvslutadBarrett EsophagusFörenta staterna