NCT00822289

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

First QC Date

January 13, 2009

Last Update Submit

January 13, 2009

Conditions

Keywords

radioactive iodineHelicobacter pyloriThyroid diseasesCagA

Outcome Measures

Secondary Outcomes (1)

  • To determine whether CagA helicobacter pylori infection is more prevalent in patients with thyroid diseases compared to other thyroid diseases

    2 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Adult patients between the ages of 18 and 80.
  • Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I).
  • Patients who provide informed consent

You may not qualify if:

  • Patients without diagnosed thyroid disease.
  • Patients who are pregnant or breast feeding.
  • Patients who have received previous treatment for H. pylori infection.
  • Patients taking proton pump inhibitors.
  • Patients with recent or current use of antibiotics.
  • Patients allergic to iodine (131I).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperthyroidismThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

February 1, 2009

Last Updated

January 14, 2009

Record last verified: 2009-01