- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00081354
Early Detection of Barrett's Esophagus
Barrett's Esophagus Early Detection Study
Background:
The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past two decades and is the most rapidly increasing cancer in the U.S.
Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125, and is considered a precursor lesion for EAC.
Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous diagnosis of BE or have been part of a surveillance program, so alternative screening methods are needed.
Objectives:
The primary goal of this project is to identify a practical blood-based biomarker(s) that can be used as a screening test to determine who has BE and who does not.
Secondary goals of the project are to characterize germ-line and tissue biomarkers associated with BE, and to compare biomarkers in non-BE patients with and without GERD.
Tertiary goals are to explore associations between biomarkers in blood or tissue and progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns over time.
Eligibility:
This study will be conducted among patients in the Barrett's Esophagus Registry (currently with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda beginning in 1992, as well as a comparison group of approximately 600 matched non-BE patients endoscoped in the GI clinic at NNMC for other conditions.
Design:
Blood and tissue samples will be collected as well as questionnaire data on risk factors and medications as well as GERD.
Data analyses will be based primarily on laboratory testing of newly collected esophageal biopsies, brush samples, and blood samples, but secondarily will also include use of archival tissue biopsy samples.
Follow up of BE Registry patients will include standard periodic surveillance endoscopies, additional blood samples, and ascertainment of disease status (i.e., progression).
To distinguish BE versus non BE-patients in this case-control study, we will:
assess predictability of BE status from serum proteomic patterns;
characterize esophageal biopsies and brush samples for selected DNA alterations, RNA expression, and proteomic profiles;
genotype patients for selected polymorphisms potentially associated with BE;
compare blood and tissue biomarkers in non-BE patients with and without GERD;
explore the association of biomarkers with progression from BE to dysplasia or EAC;
assess proteomic pattern stability over time in BE patients.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Background:
The incidence rate for esophageal adenocarcinoma (EAC) has risen 10% per year over the past two decades and is the most rapidly increasing cancer in the U.S.
Barrett's esophagus (BE), a metaplastic change from the normal squamous esophageal epithelium to a specialized intestinal-type columnar mucosa, increases the risk of EAC by 30-125 fold (1), and is considered a precursor lesion for EAC.
Individuals diagnosed with BE are currently entered into endoscopic surveillance programs to look for dysplasia or EAC. However, only 5% of subjects diagnosed with EAC have a previous diagnosis of BE or have been part of a surveillance program, so alternative screening methods are needed.
Objectives:
The primary goal of this project is to identify a practical blood-based biomarker(s) that can be used as a screening test to determine who has BE and who does not.
Secondary goals of the project are to characterize germ line and tissue biomarkers associated with BE, and to compare biomarkers in non-BE patients with and without GERD.
Tertiary goals are to explore associations between biomarkers in blood or tissue and progression from BE to dysplasia or EAC, and to assess the stability of proteomic patterns over time.
Eligibility:
This study will be conducted among patients in the Barretts Esophagus Registry (currently with 206 registrants) established at the National Naval Medical Center (NNMC) in Bethesda beginning in 1992 as well as comparison group of approximately 600 matched non-BE patients endoscoped in the GI clinic at NNMC for other conditions.
Design:
Blood and tissue samples will be collected as well as questionnaire data on risk factors and medications as well as GERD.
Data analysis will be based primarily on laboratory testing of newly collected esophageal biopsies, brush samples, and blood samples, but secondarily will also include use of archival tissue biopsy samples.
Follow-up of BE Registry patients will include standard periodic surveillance endoscopies, additional blood samples, and ascertainment of disease status (i.e, progression).
To distinguish BE versus non-BE patients, we will: (1) assess predictability of BE status from serum proteomic patters; (2) characterize esophageal biopsies and brush samples for selected DNA alterations, RNA expression, and proteomic profiles; (3) genotype patients for selected polymorphisms potentially associated with BE; (4) compare blood and tissue biomarkers in non-BE patients with and without GERD; (5) explore the association of biomarkers with progression from BE to dysplasia or EAC; and (6) assess proteomic pattern stability over time in BE patients.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forente stater, 20889
- National Naval Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
- INCLUSION CRITERIA
Inclusion criteria for EGD in this study include:
Greater than or equal to 18 years of age, and
presence of GERD or GERD-like symptoms, or
presence of BE, or
dysphagia, or
anemia, or
gastrointestinal bleeding, or
presence of other conditions (e.g., dyspepsia) that merit endoscopic evaluation.
EXCLUSION CRITERIA
Exclusion criteria for EGD in this study include:
severe pulmonary or cardiac disease, or
pregnancy, or
refusal, or
inability or refusal to give consent, or
age less than 18 years or participation in NNMC Barrett's esophagus cryotherapy protocol, or
malignancy other than nonmelanoma skin cancer.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Barrett's esophagus
|
Controls negative for Barrett's esophagus
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Case Control
Tidsramme: End of Study
|
End of Study
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michael B Cook, M.D., National Cancer Institute (NCI)
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Gerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7. doi: 10.1053/gast.2002.34748.
- di Pietro M, Lao-Sirieix P, Boyle S, Cassidy A, Castillo D, Saadi A, Eskeland R, Fitzgerald RC. Evidence for a functional role of epigenetically regulated midcluster HOXB genes in the development of Barrett esophagus. Proc Natl Acad Sci U S A. 2012 Jun 5;109(23):9077-82. doi: 10.1073/pnas.1116933109. Epub 2012 May 17.
- Yasui Y, Pepe M, Thompson ML, Adam BL, Wright GL Jr, Qu Y, Potter JD, Winget M, Thornquist M, Feng Z. A data-analytic strategy for protein biomarker discovery: profiling of high-dimensional proteomic data for cancer detection. Biostatistics. 2003 Jul;4(3):449-63. doi: 10.1093/biostatistics/4.3.449.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
- 040155
- 04-C-0155
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