- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01286155
Epidemiology of Barrett's Esophagus: A Population Based Study
To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's esophagus (BE) in the community.
To develop a population based clinical risk factor prediction model for the diagnosis of BE and identify novel risk factors for BE which would make population based screening more efficient. This will be an important first step in identifying the target population for BE screening, another crucial component of making screening feasible and efficient
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Case: Olmsted county residents > 18 years old from the barrett's esophagus (BE) incidence cohort who are still alive at the time of study.
- Control # 1 : Olmsted county residents > 18 years old that responded to a recent community based survey and reported gastroesophageal reflux (GER) symptoms at least once a week and without a known diagnosis of BE.
- Control # 2 : Olmsted county residents > 18 years old that responded to a recent community based survey that did not report any GER symptoms and without a known diagnosis of BE.
Exclusion Criteria:
Cases: BE subjects who
- Have died prior to the start of this study;
- Refuse to participate;
Controls: respondents to the "constipation survey" who
- Are known to have BE;
- Have died prior to the start of this study;
- Refuse to participate; -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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with gastroesophageal reflux disease(GERD)
Subjects with gastroesophageal reflux disease (GERD)
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Non-GERD
Subjects with no history of gastroesophageal reflux disease (GERD)
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Barrett's esophagus
Subjects with confirmed barrett's esophagus in Olmsted county
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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The primary outcome from the survey will be the proportion of patients willing to undergo an esophageal capsule study compared to those willing to undergo an endoscopic procedure (Esophagogastroduodenoscopy or transnasal endoscopy)
Tidsramme: 18 months
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18 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Study established (age, gender, ethnicity, reflux) and potential risk factors (sleep apnea, visceral adiposity, Helicobacter pylori infection, Metabolic Syndrome)to develop a clinical risk factor model for diagnosis of Barrett's esophagus(BE).
Tidsramme: 18 months
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Metabolic Syndrome (ATP III criteria, JAMA 2001; 285: 2486-97.) defined as a combination of clinical disorders that includes the presence of three or more of the following indicators:
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18 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 09-002718
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Kliniske forsøg med Barretts spiserør
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Digma Medical Ltd.Ikke rekrutterer endnu
-
NinePoint MedicalAfsluttetIntramucosal Adenocarcinom | Barrett's-associeret dysplasiHolland
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University Medical Center GroningenIkke rekrutterer endnuBarrett Esophagus Adenocarcinom | Barrett's Esophagus With or Without DysplasiaHolland
-
Erbe Elektromedizin GmbHNAMSA; Kansas City Veteran Affairs Medical Center; Erbe USA IncorporatedAfsluttetBarretts spiserør | Højgradig dysplasi i Barrett-esophagus | Lavgradig dysplasi i Barrett-esophagusForenede Stater
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Maria Sklodowska-Curie National Research Institute...Centre of Postgraduate Medical EducationAfsluttetBarretts esophagus med lavgradig dysplasi
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Tomasz RomańczykAfsluttetHeterotopisk maveslimhinde i den proksimale esophagusPolen
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Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationAfsluttetBarretts esophagus, esophageal intraepithelial neoplasiForenede Stater, Tyskland
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University Medical Center GroningenAfsluttetSpiserørskræft | Barrett Esophagus | Dysplasi i Barrett EsophagusHolland
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University Hospital, AntwerpKarolinska University Hospital; Karolinska Institutet; Rigshospitalet, Denmark og andre samarbejdspartnereIkke rekrutterer endnuBarrett Esophagus | Gastroenterologi | Barrett Esophagus Adenocarcinom | Adenocarcinom - GEJ | Gastroenterologisk kræftDanmark, Belgien, Sverige, Irland, Italien, Frankrig, Tyskland
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Coordinación de Investigación en Salud, MexicoSuspenderetIntestinal Metaplasi | Dysplasi | Barretts esophagus med lavgradig dysplasiMexico