Treatment of M.Graves With Radioactive Iodine: Follow-up... | NCT00525122

Studies
Treatment of M.Graves With Radioactive Iodine: Follow-up Study

NCT00525122

Sponsor

Medisch Centrum Rijnmond-Zuid, Netherlands

Status

Unknown status

Last Update Posted

May 22, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Hyperthyroidism

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 4, 2007

First Submission Date that Met QC Criteria

Sep 4, 2007

First Posted Date

Sep 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2008

Last Update Posted Date

May 22, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypothesis: What is the natural course after treatment with radioactive iodine in patients with hyperthyroidism?

What are the determinants for the development of acute hypo- or hyperthyroidism after treatment with radioactive iodine without antithyroid drugs?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
1		Patients with hyperthyroidism who are will be treated with radioactive iodine.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients wth hyperthyroidism who are eligible for treatment with radioactive iodine
Age > 18 years

Exclusion Criteria:

Severe ophthalmopathy
Pregnancy or wish to pregnancy on short term
Breastfeeding
Patients already treated with radioactive iodine
Known cardiovascular diseases or other severe comorbidity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients of 18 years and older with hyperthyroidism who are eligible for treatment with radioactive iodine.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
A. Berghout, MD, PhD	Contact	0031 10 2913368		BerghoutA@mcrz.nl

Overall Officials

Name	Affiliation	Role
A. Berghout, MD, PhD	Medisch Centrum Rijnmond-Zuid, Netherlands	Principal Investigator
C. van Noord, MD	Medisch Centrum Rijnmond-Zuid, Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MCRZ	Recruiting	Rotterdam	South Holland	3075 EA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D006980	Hyperthyroidism

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided