Thyroid NoduleNCT05526261
Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?
An observational study of Thyroid Nodule, run by Linkoeping University at 1 site in Sweden.
Trial summary
Nodules in the thyroid gland are common. Patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. The thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Hemithyroidectoy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 30 May 2020to 30 May 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patientens with compression symptoms in the neck
Who may be able to join
- Patients with a thyroid nodule who have local problems and where surgery (hemithyroidectomy) is planned
- 18 years or older
- Bethesda I-IV
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Linköpings University
Linköping, Östergötland County, 58729
Ervin Beka, 0738430968, ervin.beka@regionostergotland.se
About this study
Nodules in the thyroid gland are common. Patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. The thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. Thus, a lump in the thyroid gland can cause pressure symptoms from these organs. In the event of such complaints, patients are referred for investigation. If it turns out that the patient has a lump in the thyroid gland ("goiter"), further investigation is carried out with an ultrasound examination and sampling with a needle from the lump (puncture).
At present, most thyroid nodules are examined cytologically, ie the thyroid nodules are punctured with a thin needle and the cells that are obtained are analyzed by a cytologist. The material is graded according to Bethesda classification. Higher grading is associated with a higher risk that the tuber is malignant. Lower grading is associated with a lower probability that the tuber can be malignant. If these patients are operated on, it is usually with the hope that their local ailments improve.
We want to investigate which patients who have a lump in the thyroid gland and experience pressure problems experience an improvement after a thyroid operation.
- Conditions
- Thyroid Nodule
- Being tested
- Hemithyroidectoy
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemithyroidectoyProcedure or surgery
Hemithyroidectomy it is a surgical procedure where half of the thyroid gland is operated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement
Which sypmtoms become better after hemithyroidectomy
Measured: One year follow upp
Secondary outcomes (1)
Comparision of questionnaries
The patients are going to fill in 4 different questionnaries in 3 different time intervalls. Before the operation, 1 month and 1 year efter the operation.
Measured: 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start30 May 2020
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ervin Beka, Linkoeping University
- Investigators
- Oliver Gimm, Professor, Study director, Professor Oliver Gimm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526261
- Sponsor's protocol ID
- 2020-00022
- Status last verified
- Sep 2022
- First submitted
- 16 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?
- ClinicalTrials.gov ID
- NCT05526261
- Acronym / sponsor ID
- 2020-00022
- Conditions
- Thyroid Nodule
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 2 Sep 2022 (actual)
- 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.
Nodules in the thyroid gland are common. Patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. The thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. Thus, a lump in the thyroid gland can cause pressure symptoms from these organs. In the event of such complaints, patients are referred for investigation. If it turns out that the patient has a lump in the thyroid gland ("goiter"), further investigation is carried out with an ultrasound examination and sampling with a needle from the lump (puncture).
At present, most thyroid nodules are examined cytologically, ie the thyroid nodules are punctured with a thin needle and the cells that are obtained are analyzed by a cytologist. The material is graded according to Bethesda classification. Higher grading is associated with a higher risk that the tuber is malignant. Lower grading is associated with a lower probability that the tuber can be malignant. If these patients are operated on, it is usually with the hope that their local ailments improve.
We want to investigate which patients who have a lump in the thyroid gland and experience pressure problems experience an improvement after a thyroid operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patientens with compression symptoms in the neck
Key inclusion criteria (3 listed)
- Patients with a thyroid nodule who have local problems and where surgery (hemithyroidectomy) is planned
- 18 years or older
- Bethesda I-IV
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemithyroidectoyHemithyroidectomy it is a surgical procedure where half of the thyroid gland is operated. | Procedure or surgery | – |
Primary outcome
Symptom improvement
Time frame: One year follow upp
Which sypmtoms become better after hemithyroidectomy
1 secondary outcome
Comparision of questionnaries
Time frame: 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Oliver Gimm, Professor study director
Professor Oliver Gimm
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 Thyroid Nodule, run by Linkoeping University at 1 site in Sweden.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ervin Beka (0738430968, ervin.beka@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improvement (time frame: One year follow upp). It is what the study was designed to measure, not a finding.
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 2 Sep 2022.