Papillary Thyroid CarcinomaNCT06626581
Iodine Status and Characteristics of Papillary Thyroid Cancer
An observational study of Papillary Thyroid Carcinoma, run by Shandong Provincial Hospital.
Trial summary
The effect of iodine on papillary thyroid cancer has been controversial for many years. The investigators designed a cross-sectional study and aimed to explore the relationship between the serum and urine iodine levels and the clinical and molecular characteristics of papillary thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Papillary Thyroid Carcinoma
- What is being tested?
- Iodine excess and Iodine suitable
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three sub centers will be selected in high iodine areas (Jining, Liaocheng, Heze) and moderate iodine areas (Jinan, Shenyang, Harbin) respectively. People who have lived in these areas for more than 5 years and seek medical treatment in tertiary hospitals will be selected.
Who may be able to join
- Age range: 18~65 years old, gender not limited;
- Living in the residential area for at least 5 years;
- Patients diagnosed clinically with thyroid cancer and scheduled for thyroid surgery, with pathological diagnosis of papillary thyroid cancer;
- Complete clinical data: including general information, relevant laboratory tests, pathological reports, surgical reports, ultrasound reports, etc.
Who cannot join
- Pathological diagnosis of other types of thyroid cancer;
- Diagnosed with other types of cancer;
- There are serious comorbidities of the heart, liver, and kidneys;
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: A Cross-sectional Study on Iodine Status and Characteristics of Papillary Thyroid Cancer
The effect of iodine on papillary thyroid cancer has been controversial for many years. The investigators designed a cross-sectional study and aimed to explore the relationship between the serum and urine iodine levels and the clinical and molecular characteristics of papillary thyroid cancer.
- Conditions
- Papillary Thyroid Carcinoma
- Being tested
- Iodine excess, Iodine suitable
- Keywords
- iodine status, papillary thyroid carcinoma
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine excessDietary supplement
Iodine excess areas: water iodine ≥100μg/L; or urinary iodine concentration(median urinary iodine levels in children aged 8-10 years old) ≥300μg/L
Iodine suitableDietary supplement
Iodine suitable areas: water iodine ≥40μg/L and ≤100μg/L; or urinary iodine concentration(median urinary iodine levels in children aged 8-10 years old) 100-199μg/L.
| Study group | Role | What they receive |
|---|---|---|
| Excessive iodine group | Residents with papillary thyroid cancer who have lived in excessive iodine areas for a long time (5 years or more). According to the report of Shandong linstitute of Endemic Disease Prevention and Control, three sub centers were selected in excessive iodine group(Jining/Liaocheng/Heze). Receives: Dietary Supplement: Iodine excess | |
| Suitable iodine group | Residents with papillary thyroid cancer who have lived in suitable iodine areas for a long time (5 years or more). According to the report of Shandong linstitute of Endemic Disease Prevention and Control, three sub centers were selected in suitable iodine group(Jinan/Shenyang/Haerbin). Receives: Dietary Supplement: Iodine suitable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and urine iodine levels
Measured: 1 year from enrollment
TNM staging of papillary thyroid cancer
Measured: 3 month from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CarcinomaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hai-qing Zhang, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626581
- Sponsor's protocol ID
- ShandongPH 20240923
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi JY, Lee JH, Song Y. Evaluation of Iodine Status among Korean Patients with Papillary Thyroid Cancer Using Dietary and Urinary Iodine. Endocrinol Metab (Seoul). 2021 Jun;36(3):607-618. doi: 10.3803/EnM.2021.1005. Epub 2021 Jun 21.
PubMed 34154044Kim HJ, Park HK, Byun DW, Suh K, Yoo MH, Min YK, Kim SW, Chung JH. Iodine intake as a risk factor for BRAF mutations in papillary thyroid cancer patients from an iodine-replete area. Eur J Nutr. 2018 Mar;57(2):809-815. doi: 10.1007/s00394-016-1370-2. Epub 2017 Mar 3.
PubMed 28258306Zhang X, Zhang F, Li Q, Aihaiti R, Feng C, Chen D, Zhao X, Teng W. The relationship between urinary iodine concentration and papillary thyroid cancer: A systematic review and meta-analysis. Front Endocrinol (Lausanne). 2022 Oct 31;13:1049423. doi: 10.3389/fendo.2022.1049423. eCollection 2022.
PubMed 36387866Kim K, Cho SW, Park YJ, Lee KE, Lee DW, Park SK. Association between Iodine Intake, Thyroid Function, and Papillary Thyroid Cancer: A Case-Control Study. Endocrinol Metab (Seoul). 2021 Aug;36(4):790-799. doi: 10.3803/EnM.2021.1034. Epub 2021 Aug 11.
PubMed 34376043Lee JH, Hwang Y, Song RY, Yi JW, Yu HW, Kim SJ, Chai YJ, Choi JY, Lee KE, Park SK. Relationship between iodine levels and papillary thyroid carcinoma: A systematic review and meta-analysis. Head Neck. 2017 Aug;39(8):1711-1718. doi: 10.1002/hed.24797. Epub 2017 May 17.
PubMed 28513893
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on Iodine Status and Characteristics of Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06626581
- Acronym / sponsor ID
- ShandongPH 20240923
- Conditions
- Papillary Thyroid Carcinoma
- Keywords
- iodine status, papillary thyroid carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Oct 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 effect of iodine on papillary thyroid cancer has been controversial for many years. The investigators designed a cross-sectional study and aimed to explore the relationship between the serum and urine iodine levels and the clinical and molecular characteristics of papillary thyroid cancer.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excessive iodine group | – | Dietary Supplement: Iodine excessResidents with papillary thyroid cancer who have lived in excessive iodine areas for a long time (5 years or more). According to the report of Shandong linstitute of Endemic Disease Prevention and Control, three sub centers were selected in excessive iodine group(Jining/Liaocheng/Heze). |
| Suitable iodine group | – | Dietary Supplement: Iodine suitableResidents with papillary thyroid cancer who have lived in suitable iodine areas for a long time (5 years or more). According to the report of Shandong linstitute of Endemic Disease Prevention and Control, three sub centers were selected in suitable iodine group(Jinan/Shenyang/Haerbin). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three sub centers will be selected in high iodine areas (Jining, Liaocheng, Heze) and moderate iodine areas (Jinan, Shenyang, Harbin) respectively. People who have lived in these areas for more than 5 years and seek medical treatment in tertiary hospitals will be selected.
Key inclusion criteria (4 listed)
- Age range: 18~65 years old, gender not limited;
- Living in the residential area for at least 5 years;
- Patients diagnosed clinically with thyroid cancer and scheduled for thyroid surgery, with pathological diagnosis of papillary thyroid cancer;
- Complete clinical data: including general information, relevant laboratory tests, pathological reports, surgical reports, ultrasound reports, etc.
Key exclusion criteria (3 listed)
- Pathological diagnosis of other types of thyroid cancer;
- Diagnosed with other types of cancer;
- There are serious comorbidities of the heart, liver, and kidneys;
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 |
|---|---|---|
| Iodine excessIodine excess areas: water iodine ≥100μg/L; or urinary iodine concentration(median urinary iodine levels in children aged 8-10 years old) ≥300μg/L | Dietary supplement | Excessive iodine group |
| Iodine suitableIodine suitable areas: water iodine ≥40μg/L and ≤100μg/L; or urinary iodine concentration(median urinary iodine levels in children aged 8-10 years old) 100-199μg/L. | Dietary supplement | Suitable iodine group |
Primary outcome
Serum and urine iodine levels
Time frame: 1 year from enrollment
TNM staging of papillary thyroid cancer
Time frame: 3 month from enrollment
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 4 Oct 2024.
- Results publication: PubMed 34154044Choi JY, Lee JH, Song Y. Evaluation of Iodine Status among Korean Patients with Papillary Thyroid Cancer Using Dietary and Urinary Iodine. Endocrinol Metab (Seoul). 2021 Jun;36(3):607-618. doi: 10.3803/EnM.2021.1005. Epub 2021 Jun 21.
- Results publication: PubMed 28258306Kim HJ, Park HK, Byun DW, Suh K, Yoo MH, Min YK, Kim SW, Chung JH. Iodine intake as a risk factor for BRAF mutations in papillary thyroid cancer patients from an iodine-replete area. Eur J Nutr. 2018 Mar;57(2):809-815. doi: 10.1007/s00394-016-1370-2. Epub 2017 Mar 3.
- Results publication: PubMed 36387866Zhang X, Zhang F, Li Q, Aihaiti R, Feng C, Chen D, Zhao X, Teng W. The relationship between urinary iodine concentration and papillary thyroid cancer: A systematic review and meta-analysis. Front Endocrinol (Lausanne). 2022 Oct 31;13:1049423. doi: 10.3389/fendo.2022.1049423. eCollection 2022.
- Results publication: PubMed 34376043Kim K, Cho SW, Park YJ, Lee KE, Lee DW, Park SK. Association between Iodine Intake, Thyroid Function, and Papillary Thyroid Cancer: A Case-Control Study. Endocrinol Metab (Seoul). 2021 Aug;36(4):790-799. doi: 10.3803/EnM.2021.1034. Epub 2021 Aug 11.
- Results publication: PubMed 28513893Lee JH, Hwang Y, Song RY, Yi JW, Yu HW, Kim SJ, Chai YJ, Choi JY, Lee KE, Park SK. Relationship between iodine levels and papillary thyroid carcinoma: A systematic review and meta-analysis. Head Neck. 2017 Aug;39(8):1711-1718. doi: 10.1002/hed.24797. Epub 2017 May 17.
- Individual participant dataSharing planned: No
Related trials for Papillary Thyroid Carcinoma
Recruiting
Active Surveillance of Papillary Thyroid Microcarcinoma
Papillary Thyroid Microcarcinoma
RecruitingObservational study
Definition of Mutational Profile of Papillary Thyroid Tumors by Mass-ARRAY
Papillary Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
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 Papillary Thyroid Carcinoma, run by Shandong Provincial Hospital.
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 4 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: opening soon, as of the sponsor's last update on 4 Oct 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 Qingling Guo (+86-0531-68776375, guoqinglingqhb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and urine iodine levels (time frame: 1 year from enrollment). The study lists 2 primary outcomes in all. 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 NCT06626581, which also lists 5 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 4 Oct 2024.