Status:
UNKNOWN
Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
Conditions:
Intestinal Metaplasia
Intestinal Dysplasia
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
Brief Summary
The investigators hypothesis that 1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable 2. pCL...
Detailed Description
Patients will be recruited from an ongoing study - Gastric Cancer Epidemiology, Clinical and Genetic Programme Cohort Study (GCEP). GCEP is a prospective cohort study aiming to enroll 3,000 Singapore-...
Eligibility Criteria
Inclusion
- The subject is Chinese
- The subject is greater than 50 years of age
- The subject satisfies one or more of the following criteria:
- has (had) a history of dyspepsia of at least 4 weeks or more. Dyspeptic symptoms include bloating, epigastric discomfort and early satiety
- has a family history of gastric cancer
- has a medical condition for which an OGD is indicated.
- Has past history of intestinal metaplasia or dysplasia
- The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
- The subject must be willing and able to comply with scheduled visits and other study procedures
Exclusion
- patients who cannot undergo gastroscopies
- have a personal history of stomach cancer or surgery
- any disabling illnesses
- are pregnant or breast-feeding
- have bronchial asthma or a known allergy to fluorescein
- have renal impairment with serum creatinine above the upper limit of normal
- have uncorrected coagulopathy or severe thrombocytopenia precluding biopsy
- unable to provide informed consent
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01398579
Start Date
September 1 2011
End Date
September 1 2012
Last Update
July 12 2012
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, Singapore, 119974