Thyroid NoduleNCT05658809
Intervention in Single Thyroid Nodule.
A study testing thyroidectomy in people with Thyroid Nodule, run by Assiut University.
Trial summary
Thyroid nodules are common clinical problem. The incidence is 2-4 per 100,000 people per year, being more common in women and the elderly. thyroid nodule is a "discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2022to 30 Dec 2023
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years.
- patients with single thyroid lesion
- Fit for surgery
Who cannot join
- patients with age less than 20 years and more than 60 years.
- patients with multiple thyroid lesions.
- patients with advanced and metastatic malignancy.
- Unfit for surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Total Thyroidectomy Versus Hemithyroidectomy for Patients With Single Thyroid Nodule , Prospective Comparative Study
Thyroid nodules are common clinical problem. The incidence is 2-4 per 100,000 people per year, being more common in women and the elderly. thyroid nodule is a "discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are asymptomatic, may present as neck swelling
Read the detailed description
Thyroid nodular disease comprises of a wide range of disorders. Benign forms such as colloid nodules,cysts and thyroiditis are more comman than benign follicular neoplasms and thyroid carcinomas. Incidence of malignancy ranges from 10% to 30% in solitary thyroid nodule(STN).Studies have shown that the occurrence of malignancy is higher in case of solitary thyroid nodule compared to multinodular goitres. Preoperative evaluation of thyroid nodules is important in distinguishing between benign and malignant thyroid nodules and also in treatment to avoid unnecessary extensive surgery and its complications. Fine needle aspiration biopsy (FNAB) is the most common method of examining solitary thyroid nodules today.Total thyroidectomy and lobectomy remain the main primary surgical interventions for single thyroid nodule. There is debat between total thyroidectomy and hemithyroidectomy for patients with single thyroid nodule. our study is for comparing between total thyroidectomy and hemi thyroidectomy in single thyroid nodule
- Conditions
- Thyroid Nodule
- Being tested
- thyroidectomy
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
Patients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Total thyroidectomy for single thyroid nodule | Active comparator | group of participants will be treated with total thyroidectomy Receives: Procedure: thyroidectomy |
| Hemithyroidectomy for single thyroid nodule | Active comparator | 2nd group of participants will be treated with hemithyroidectomy Receives: Procedure: thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates
Compare between total thyroidectomy and hemithyroidectomy in patients with single thyroid nodule to improve the management of single thyroid nodule in general surgery department , Assiut university hospital.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start30 Dec 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thyroid NoduleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Anter Ali Abdelhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658809
- Sponsor's protocol ID
- THYSINGLE
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hurtado-Lopez LM, Arellano-Montano S, Torres-Acosta EM, Zaldivar-Ramirez FR, Duarte-Torres RM, Alonso-De-Ruiz P, Martinez-Duncker I, Martinez-Duncker C. Combined use of fine-needle aspiration biopsy, MIBI scans and frozen section biopsy offers the best diagnostic accuracy in the assessment of the hypofunctioning solitary thyroid nodule. Eur J Nucl Med Mol Imaging. 2004 Sep;31(9):1273-9. doi: 10.1007/s00259-004-1544-7. Epub 2004 May 6.
PubMed 15133637Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967Jena A, Patnayak R, Prakash J, Sachan A, Suresh V, Lakshmi AY. Malignancy in solitary thyroid nodule: A clinicoradiopathological evaluation. Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):498-503. doi: 10.4103/2230-8210.159056.
PubMed 26180765Lloyd RV, Buehler D, Khanafshar E. Papillary thyroid carcinoma variants. Head Neck Pathol. 2011 Mar;5(1):51-6. doi: 10.1007/s12105-010-0236-9. Epub 2011 Jan 8.
PubMed 21221869Alwithenani R, DeBrabandere S, Rachinsky I, MacNeil SD, Badreddine M, Van Uum S. Performance of the American Thyroid Association Risk Classification in a Single Center Cohort of Pediatric Patients with Differentiated Thyroid Cancer: A Retrospective Study. J Thyroid Res. 2019 Jun 2;2019:5390316. doi: 10.1155/2019/5390316. eCollection 2019.
PubMed 31275541Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012 Mar;96(2):329-49. doi: 10.1016/j.mcna.2012.02.002.
PubMed 22443979
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Thyroidectomy Versus Hemithyroidectomy for Patients With Single Thyroid Nodule , Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT05658809
- Acronym / sponsor ID
- THYSINGLE
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Dec 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.
Thyroid nodules are common clinical problem. The incidence is 2-4 per 100,000 people per year, being more common in women and the elderly. thyroid nodule is a "discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. Most thyroid nodules are asymptomatic, may present as neck swelling
Detailed description
Thyroid nodular disease comprises of a wide range of disorders. Benign forms such as colloid nodules,cysts and thyroiditis are more comman than benign follicular neoplasms and thyroid carcinomas. Incidence of malignancy ranges from 10% to 30% in solitary thyroid nodule(STN).Studies have shown that the occurrence of malignancy is higher in case of solitary thyroid nodule compared to multinodular goitres. Preoperative evaluation of thyroid nodules is important in distinguishing between benign and malignant thyroid nodules and also in treatment to avoid unnecessary extensive surgery and its complications. Fine needle aspiration biopsy (FNAB) is the most common method of examining solitary thyroid nodules today.Total thyroidectomy and lobectomy remain the main primary surgical interventions for single thyroid nodule. There is debat between total thyroidectomy and hemithyroidectomy for patients with single thyroid nodule. our study is for comparing between total thyroidectomy and hemi thyroidectomy in single thyroid nodule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total thyroidectomy for single thyroid nodule | Active comparator | Procedure: thyroidectomygroup of participants will be treated with total thyroidectomy |
| Hemithyroidectomy for single thyroid nodule | Active comparator | Procedure: thyroidectomy2nd group of participants will be treated with hemithyroidectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 20 to 60 years.
- patients with single thyroid lesion
- Fit for surgery
Key exclusion criteria (4 listed)
- patients with age less than 20 years and more than 60 years.
- patients with multiple thyroid lesions.
- patients with advanced and metastatic malignancy.
- Unfit for surgery
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 |
|---|---|---|
| thyroidectomyPatients will be divided into 2 groups group will be treated with total thyroidectomy and the other group will be treated with hemithyroidectomy | Procedure or surgery | Hemithyroidectomy for single thyroid nodule, Total thyroidectomy for single thyroid nodule |
Primary outcome
Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates
Time frame: one year
Compare between total thyroidectomy and hemithyroidectomy in patients with single thyroid nodule to improve the management of single thyroid nodule in general surgery department , Assiut university hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Background: PubMed 15133637Hurtado-Lopez LM, Arellano-Montano S, Torres-Acosta EM, Zaldivar-Ramirez FR, Duarte-Torres RM, Alonso-De-Ruiz P, Martinez-Duncker I, Martinez-Duncker C. Combined use of fine-needle aspiration biopsy, MIBI scans and frozen section biopsy offers the best diagnostic accuracy in the assessment of the hypofunctioning solitary thyroid nodule. Eur J Nucl Med Mol Imaging. 2004 Sep;31(9):1273-9. doi: 10.1007/s00259-004-1544-7. Epub 2004 May 6.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Background: PubMed 26180765Jena A, Patnayak R, Prakash J, Sachan A, Suresh V, Lakshmi AY. Malignancy in solitary thyroid nodule: A clinicoradiopathological evaluation. Indian J Endocrinol Metab. 2015 Jul-Aug;19(4):498-503. doi: 10.4103/2230-8210.159056.
- Background: PubMed 21221869Lloyd RV, Buehler D, Khanafshar E. Papillary thyroid carcinoma variants. Head Neck Pathol. 2011 Mar;5(1):51-6. doi: 10.1007/s12105-010-0236-9. Epub 2011 Jan 8.
- Background: PubMed 31275541Alwithenani R, DeBrabandere S, Rachinsky I, MacNeil SD, Badreddine M, Van Uum S. Performance of the American Thyroid Association Risk Classification in a Single Center Cohort of Pediatric Patients with Differentiated Thyroid Cancer: A Retrospective Study. J Thyroid Res. 2019 Jun 2;2019:5390316. doi: 10.1155/2019/5390316. eCollection 2019.
- Background: PubMed 22443979Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012 Mar;96(2):329-49. doi: 10.1016/j.mcna.2012.02.002.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing thyroidectomy in people with Thyroid Nodule, 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 4 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 21 Dec 2022. 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 Mohamed S. Shahine, Phd (01025555420, msafwat67@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the management of single thyroid nodule to reduce the morbidity and mortality rates (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658809, which also lists 6 linked publications.
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 21 Dec 2022.