Thyroid CancerNCT06730971
This Study is Mainly About Finding Incidence Among Other Factors of Thyroid Cancer in Patient with Benign Disease As MNG to Early Discover of the Malignancy to Save the Patient from Aggressive Procedure
An observational study of Thyroid Cancer, run by Asmaa Mohamed Emam.
Trial summary
The purpose of the present study was to evaluate the prevalence of thyroid cancer in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Total thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with inclusion criteria of various ages ,sex and BMI
Who may be able to join
- Male or Female patients with multinodular goiter Patients with normal thyroid function tests Patients with FNAC negative for malignancy Patients who are fit for general anesthesia
Who cannot join
- patient suspicious nodule on ultrasound imaging patients in whom distant metastases occurred preoperatively but FNAC was negative for malignancy patients with a history of thyroidectomy Patients with severe comorbid conditions with high risk for general anesthesia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Incidence, Types and Risk Factors for Thyroid Cancer in Patients with Multinodular Goitre , Prospective Study.
The purpose of the present study was to evaluate the prevalence of thyroid cancer in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy.
Read the detailed description
Multinodular goiter (MNG) is a common thyroid disorder characterized by the presence of multiple nodules in the thyroid gland. It is a benign condition, but a proportion of patients with MNG have risk of developing thyroid cancer .
Thyroid carcinoma is one of the most frequent types of endocrinological cancers, and its occurrence has been on the rise globally. Total thyroidectomy is regarded as the most effective surgical treatment for MNG and is also advised for patients with diagnosed thyroid cancer.
Several studies have revealed a greater incidence of thyroid cancer in MNG. Published data regarding the prevalence of thyroid cancer within a multinodular goitre (MNG) have demonstrated a wide distribution of cancer rates, ranging from 3 to 35 percent.
Although fine-needle aspiration (FNA) is the most accurate and cost effective method of thyroid nodule evaluation, benign cytological -diagnosis is associated with false-negative. Further complicating this topic, FNA cytology may be non-diagnostic in up to 25 per cent of patients with nodular thyroid disease, and its performance in the setting of MNG presents other difficulties, including deeply located thyroid nodules that may be more challenging to aspirate as well as reliably evaluating all suspicious nodules.
Incidental thyroid cancer (ITC) is sometimes detected in the final pathological examination, the incidence of ITC after surgery varies widely in literature, ranging from 2% to 30%.
Certain risk factors, such as sex, age, history of neck irradiation, family history, calcifications observed during imaging studies, size of the thyroid tumor and thyroid-stimulating hormone (TSH) levels, may be related to ITC; however, this remains controversial. Although previous studies have focused on clinical factors related to cancer, the knowledge on pathologic characteristics of ITC is limited.
- Conditions
- Thyroid Cancer
- Being tested
- Total thyroidectomy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
Post operative specimen after total thyroidectomy
Total thyroidectomyProcedure or surgery
Remove of both thyroid lobes and isthmus
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the prevalence of Incidental thyroid cancer (ITC) in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asmaa Mohamed Emam
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Asmaa Mohamed Emam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730971
- Sponsor's protocol ID
- Thyroid cancer in MNG
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haugen 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 26462967Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Amin A, Amjad A, Farman G, Khaliq SU, Amin L, Khan M. Frequency and Type of Thyroid Carcinoma in Patients With Multinodular Goiter. Cureus. 2023 Apr 21;15(4):e37921. doi: 10.7759/cureus.37921. eCollection 2023 Apr.
PubMed 37220458
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Types and Risk Factors for Thyroid Cancer in Patients with Multinodular Goitre , Prospective Study.
- ClinicalTrials.gov ID
- NCT06730971
- Acronym / sponsor ID
- Thyroid cancer in MNG
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asmaa Mohamed EmamUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Dec 2024 (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.
The purpose of the present study was to evaluate the prevalence of thyroid cancer in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy.
Detailed description
Multinodular goiter (MNG) is a common thyroid disorder characterized by the presence of multiple nodules in the thyroid gland. It is a benign condition, but a proportion of patients with MNG have risk of developing thyroid cancer .
Thyroid carcinoma is one of the most frequent types of endocrinological cancers, and its occurrence has been on the rise globally. Total thyroidectomy is regarded as the most effective surgical treatment for MNG and is also advised for patients with diagnosed thyroid cancer.
Several studies have revealed a greater incidence of thyroid cancer in MNG. Published data regarding the prevalence of thyroid cancer within a multinodular goitre (MNG) have demonstrated a wide distribution of cancer rates, ranging from 3 to 35 percent.
Although fine-needle aspiration (FNA) is the most accurate and cost effective method of thyroid nodule evaluation, benign cytological -diagnosis is associated with false-negative. Further complicating this topic, FNA cytology may be non-diagnostic in up to 25 per cent of patients with nodular thyroid disease, and its performance in the setting of MNG presents other difficulties, including deeply located thyroid nodules that may be more challenging to aspirate as well as reliably evaluating all suspicious nodules.
Incidental thyroid cancer (ITC) is sometimes detected in the final pathological examination, the incidence of ITC after surgery varies widely in literature, ranging from 2% to 30%.
Certain risk factors, such as sex, age, history of neck irradiation, family history, calcifications observed during imaging studies, size of the thyroid tumor and thyroid-stimulating hormone (TSH) levels, may be related to ITC; however, this remains controversial. Although previous studies have focused on clinical factors related to cancer, the knowledge on pathologic characteristics of ITC is limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with inclusion criteria of various ages ,sex and BMI
Key inclusion criteria (1 listed)
- Male or Female patients with multinodular goiter Patients with normal thyroid function tests Patients with FNAC negative for malignancy Patients who are fit for general anesthesia
Key exclusion criteria (1 listed)
- patient suspicious nodule on ultrasound imaging patients in whom distant metastases occurred preoperatively but FNAC was negative for malignancy patients with a history of thyroidectomy Patients with severe comorbid conditions with high risk for general anesthesia
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 |
|---|---|---|
| Total thyroidectomyPost operative specimen after total thyroidectomy | Procedure or surgery | – |
| Total thyroidectomyRemove of both thyroid lobes and isthmus | Procedure or surgery | – |
Primary outcome
Evaluate the prevalence of Incidental thyroid cancer (ITC) in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy.
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- 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 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 37220458Amin A, Amjad A, Farman G, Khaliq SU, Amin L, Khan M. Frequency and Type of Thyroid Carcinoma in Patients With Multinodular Goiter. Cureus. 2023 Apr 21;15(4):e37921. doi: 10.7759/cureus.37921. eCollection 2023 Apr.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Asmaa Mohamed Emam.
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 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: opening soon, as of the sponsor's last update on 12 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Emam (asmaaemam141@gmail.com ext. 2001002073861, asmaaemam141@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the prevalence of Incidental thyroid cancer (ITC) in patients who had thyroidectomy for MNG, and analyze patient-related parameters to identify type and risk factors associated with incidental thyroid malignancy. (time frame: 1 month). 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 NCT06730971, which also lists 3 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 12 Dec 2024.