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Sponsored by: |
Rabin Medical Center |
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Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00822289 |
Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori. Also to test the hypothesis that CagA virulent strains of H.pylori are more common in patients with thyroid cancer than with other thyroid diseases.
Condition |
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Helicobacter Pylori Infected Patients Thyroid Cancer Patients Hyperthyroidism |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effect of Radioactive Iodine on Eradication of Helicobacter Pylori in Patients Treated for Thyroid Diseases |
Estimated Enrollment: | 120 |
Study Start Date: | February 2009 |
Objective To test eradicate H.pylori after administration of radioactive iodine (131I) to patients with thyroid diseases and to evaluate their H.pylori CagA status .
Design Observational study
Setting
The Isotopic Institute at the Rabin Medical Center, Campus Beilinson Patients Consecutive patients with thyroid diseases referred to the Isotopic Institute at the Rabin Medical Center, Campus Beilinson for either radioactive iodine (131I) thyroid scan or radioactive iodine (131I)treatment for their disease, will be screened, prior to the radioactive iodine, for H. pylori infection and CagA protein by serology. Patient with positive serology for H. pylori will be tested for active gastric infection using the H.pylori stool antigen test. The study population will include all patients who tested positive for H.pylori both by serology and stool antigen tests. Six to eight weeks and 6 month after administration of radioactive iodine (131I) treatment , stool antigen or H.pylori will be tested again to confirm persistence of H.pylori eradication.
Main Outcome Measure confirmed H.pylori eradication by the stool antigen test. The rate of infection with virulent and caricogenic CagA H.pylori ,will be tested using the immunoblot assay.
Summary
We will test in this study whether Helicobacter pylori is eradicated, after radioactive iodine (131I) administration, from the stomach of patients with thyroid diseases. The rate of CagA virulent and carcinogenic H.pylori infection in theses patients will be assessed.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Consecutive patients with thyroid diseases referred to the Isotopic Institute at the Rabin Medical Center, Campus Beilinson for either radioactive iodine (131I) thyroid scan or radioactive iodine (131I)treatment for their disease, will be tested, prior to the radioactive iodine, for H. pylori infection and CagA protein by serology. Patient with positive serology for H. pylori will be tested for active gastric infection using the H.pylori stool antigen test. The study population will include all patients who tested positive for H.pylori both on serology and stool antigen tests. Six to eight weeks and 6 month after administration of radioactive iodine (131I) , stool antigen or H.pylori will be tested again to confirm persistence of H.pylori eradication.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Rabin Medical Center ( Haim Shmuely, MD ) |
Study ID Numbers: | 5071 |
Study First Received: | January 13, 2009 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00822289 History of Changes |
Health Authority: | Israel: Ministry of Health |
radioactive iodine Helicobacter pylori Thyroid diseases CagA |
Anti-Infective Agents Anti-Infective Agents, Local Thyroid Neoplasms Head and Neck Neoplasms Iodine Endocrine System Diseases |
Trace Elements Micronutrients Endocrinopathy Hyperthyroidism Thyroid Diseases Endocrine Gland Neoplasms |
Anti-Infective Agents Thyroid Neoplasms Growth Substances Physiological Effects of Drugs Endocrine System Diseases Trace Elements Pharmacologic Actions Anti-Infective Agents, Local Neoplasms |
Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Iodine Micronutrients Hyperthyroidism Thyroid Diseases Endocrine Gland Neoplasms |