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Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia (R-CE-GCEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01384201
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 28, 2011
Information provided by:

Study Description
Brief Summary:
This is a prospective randomised study investigating the use of chromoendoscopy and confocal laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of gastric cancer.

Condition or disease
Gastric Intestinal Metaplasia

Detailed Description:
This is a prospective randomised study investigating the use of chromoendoscopy and confocal laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of gastric cancer. Patients are randomised to undergo upper endoscopy using either confocal laser endomicroscopy or standard whitelight endoscopy to investigate for gastric preneoplastic and neoplastic lesions.Results are compared to histopathologic diagnosis made on biopsies obtained during endoscopy.

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Evaluation of the Use of Confocal Endomicroscopy in Conjunction With Chromoendoscopy in the Detection of Gastric Preneoplastic Neoplasia and Neoplasia in a High-Risk Population (R-CE-GCEP)
Study Start Date : August 2007
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Confocal Laser Endomicroscopy
OGD by Confocal Endomicroscopy
White light endoscopy
OGD by whitelight endoscopy

Outcome Measures

Primary Outcome Measures :
  1. Diagnostic yield [ Time Frame: On histopathologic diagnosis, usually 1-2 days after endoscopy ]
    The diagnostic yield, number of tissue biopsies per patient and percentage of missed lesions for CLE arm will be obtained by analyzing as though only targeted tissue biopsies are taken (CLE-TB), meaning that tissue biopsy is considered to have been performed only if the endoscopist gave the CLE diagnosis of GIM, dysplasia or malignancy. If the CLE diagnosis is normal, targeted tissue biopsy will be analyzed as not having been taken, and the corresponding histology for that site is for documenting any misdiagnosis by CLE in this study.

Biospecimen Retention:   None Retained
Biopsies from the stomach

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese, above 50 years old, at high risk of gastric cancer

Inclusion Criteria:

  1. The subject is Chinese
  2. The subject is greater than 50 years of age
  3. 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.
  4. 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.
  5. The subject must be willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

  1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
  2. The subject with liver cirrhosis.
  3. The subject with previous total or partial gastrectomy.
  4. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy.
  5. The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
  6. The subject is currently on anti-coagulant therapy such as warfarin. Patients on aspirin, ticlopidine and clopidogrel must undergo a one-week washout period before enroling in the study.
  7. The subject has a history of bronchial asthma, or a known allergy to fluorescein.
  8. The subject is unwilling or unable to provide signed informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384201

National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Khay Guan Yeoh, MBBS; M Med National University Health System
More Information

Responsible Party: Associate Professor Yeoh Khay Guan, National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT01384201     History of Changes
Other Study ID Numbers: NMRC/TCR/001/2007/CLE
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by National University Hospital, Singapore:
intestinal metaplasia, gastric cancer

Additional relevant MeSH terms:
Pathologic Processes