Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081354
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2004-04-09
Brief Title:
Early Detection of Barretts Esophagus
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Barretts Esophagus Early Detection Study
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 US
Barretts 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 biomarkers 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 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 ie 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
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 US
Barretts 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 biomarkers 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 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 ie 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
Detailed Description:
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 US
Barretts 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 biomarkers 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 ie 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
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 US
Barretts 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 biomarkers 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0155 | None | None | None |