Hyperthyreosis and GoiterNCT01384786
The Incidence of Thyroid Cancer in 4474 Patients Treated for Hyperthyroidism or Goiter
An observational study of Hyperthyreosis and Goiter and Thyroid Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan before they are treated with radioiodine for their thyroid disease. Because the investigators do not get a histologically/final diagnosis the investigators want to make sure, that the patients treated do not have a thyroid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthyreosis and Goiter, Thyroid Cancer
- How many people
- 4,474 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2004to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Radioiodine treated patients
Who may be able to join
- all patients treated with radioiodine
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan before they are treated with radioiodine for their thyroid disease. Because the investigators do not get a histologically/final diagnosis the investigators want to make sure, that the patients treated do not have a thyroid cancer when treated.
The investigators have found that thyroid cancer is not overlooked.
- Conditions
- Hyperthyreosis and Goiter, Thyroid Cancer
- Medical subject headings
- Goiter, Thyroid Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startOct 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperthyreosis and GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Investigators
- Anders Vej-Hansen, Study chair, Herlev Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384786
- Sponsor's protocol ID
- JCEM070948
- Status last verified
- Jun 2011
- First submitted
- 28 Jun 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Thyroid Cancer in 4474 Patients Treated for Hyperthyroidism or Goiter
- ClinicalTrials.gov ID
- NCT01384786
- Acronym / sponsor ID
- JCEM070948
- Conditions
- Hyperthyreosis and Goiter, Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,474 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Jul 2005 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan before they are treated with radioiodine for their thyroid disease. Because the investigators do not get a histologically/final diagnosis the investigators want to make sure, that the patients treated do not have a thyroid cancer when treated.
The investigators have found that thyroid cancer is not overlooked.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Radioiodine treated patients
Key inclusion criteria (1 listed)
- all patients treated with radioiodine
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Vej-Hansen study chair
Herlev Hospital, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyreosis and Goiter and Thyroid Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.