Level of Thyrogobulin in Different Thyroid NodulesNCT06157632
Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules
A study testing Thyriodectomy in people with Level of Thyrogobulin in Different Thyroid Nodules, run by Assiut University.
Trial summary
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Level of Thyrogobulin in Different Thyroid Nodules
- What is being tested?
- Thyriodectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 25 Nov 2024
- Phase
- Interventional
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age between 15 to 70 years old
- patients with solitary thyroid nodules
- pateints who are fit for surgeries
Who cannot join
- 1_patients who are unfit for surgeries
- 2 age below 15 years and above 70 years old
- 3-patients with thyroid nodule receiving drugs that affect thyroglobulin level as iodine
Trial locations and contacts
No sites are listed yet.
About this study
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules
Read the detailed description
Incidence of thyroid nodules varies according to the methods of diagnosis, 4-7% by palpation and 17-67% by high resolution ultrasound.
The gold standard of diagnosis for thyroid nodules is fine needle aspiration (FNA); however, fine needle aspiration cytology (FNAC) alone is insufficient to detect cancer because of inadequate cytology (5-15%) and in cases of follicular neoplasm (15-25%) where only surgery is diagnostically conclusive. Therefore, other factors in addition to FNA should be considered to predict malignancy. This study is done to evaluate the association between elevated pre-operative thyroglobulin levels and histopathologically proven thyroid carcinoma.
Metabolism of thyroglobulin occurs in the liver and via thyroid gland and recycling of the protein takes place. Circulating thyroglobulin features a half lifetime of 65 hours. Following thyroidectomy, it will take many weeks before thyroglobulin levels become undetectable. After thyroglobulin levels become undetectable (following thyroidectomy), levels are often serially monitored.
A subsequent elevation of the thyroglobulin level is an indicator of recurrence of papillary or follicular thyroid carcinoma. Hence, thyroglobulin levels in the blood are mainly used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Thyroglobulin is not produced by medullary or anaplastic carcinoma.
Therefore, this study tries to evaluate the association between the preoperative thyroglobulin levels and thyroid carcinoma proven by post-operative histopathology.
- Being tested
- Thyriodectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyriodectomyProcedure or surgery
Thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients with thyoid nodules | Other | Patients with thyroid nodules that will do thyroidectomy Receives: Procedure: Thyriodectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules
Use of serum thyroglobulin to differentiate between different thyroid nodules preoperoperatively
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion18 Nov 2024 (estimated)
- Study completion25 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Level of Thyrogobulin in Different Thyroid NodulesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients with thyoid nodules that will do thyriodectomy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Hussein Hasan, Assiut University
- Investigators
- Mohamed Baker, Prof, Study director, Assiut UniversityMahmoud Thabet, Assistant.prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157632
- Sponsor's protocol ID
- Thyroglobulin level
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules
- ClinicalTrials.gov ID
- NCT06157632
- Acronym / sponsor ID
- Thyroglobulin level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 18 Nov 2024 (estimated)
- Study completion
- 25 Nov 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules
Detailed description
Incidence of thyroid nodules varies according to the methods of diagnosis, 4-7% by palpation and 17-67% by high resolution ultrasound.
The gold standard of diagnosis for thyroid nodules is fine needle aspiration (FNA); however, fine needle aspiration cytology (FNAC) alone is insufficient to detect cancer because of inadequate cytology (5-15%) and in cases of follicular neoplasm (15-25%) where only surgery is diagnostically conclusive. Therefore, other factors in addition to FNA should be considered to predict malignancy. This study is done to evaluate the association between elevated pre-operative thyroglobulin levels and histopathologically proven thyroid carcinoma.
Metabolism of thyroglobulin occurs in the liver and via thyroid gland and recycling of the protein takes place. Circulating thyroglobulin features a half lifetime of 65 hours. Following thyroidectomy, it will take many weeks before thyroglobulin levels become undetectable. After thyroglobulin levels become undetectable (following thyroidectomy), levels are often serially monitored.
A subsequent elevation of the thyroglobulin level is an indicator of recurrence of papillary or follicular thyroid carcinoma. Hence, thyroglobulin levels in the blood are mainly used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Thyroglobulin is not produced by medullary or anaplastic carcinoma.
Therefore, this study tries to evaluate the association between the preoperative thyroglobulin levels and thyroid carcinoma proven by post-operative histopathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with thyoid nodules that will do thyriodectomy
| Arm | Type | Receives |
|---|---|---|
| Patients with thyoid nodules | Other | Procedure: ThyriodectomyPatients with thyroid nodules that will do thyroidectomy |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- age between 15 to 70 years old
- patients with solitary thyroid nodules
- pateints who are fit for surgeries
Key exclusion criteria (3 listed)
- 1_patients who are unfit for surgeries
- 2 age below 15 years and above 70 years old
- 3-patients with thyroid nodule receiving drugs that affect thyroglobulin level as iodine
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 |
|---|---|---|
| ThyriodectomyThyroidectomy | Procedure or surgery | Patients with thyoid nodules |
Primary outcome
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules
Time frame: Two year
Use of serum thyroglobulin to differentiate between different thyroid nodules preoperoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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.
Mohamed Baker, Prof study director
Assiut University
Mahmoud Thabet, Assistant.prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Thyriodectomy in people with Level of Thyrogobulin in Different Thyroid Nodules, run by Assiut University.
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 3 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Gamal, Master (01062142009, Gamal8431@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules (time frame: Two year). 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 6 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.