Clinical trial: Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia (NCT01384201)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment