Clinical trial NCT06626581: Iodine Status and Characteristics of Papillary Thyroid Cancer
Official title: A Cross-sectional Study on Iodine Status and Characteristics of Papillary Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Papillary Thyroid Carcinoma
Keywords: iodine status
papillary thyroid carcinoma
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pathological diagnosis of other types of thyroid cancer;
* Diagnosed with other types of cancer;
* There are serious comorbidities of the heart, liver, and kidneys;

Primary outcomes:
measure: Serum and urine iodine levels
timeFrame: 1 year from enrollment
measure: TNM staging of papillary thyroid cancer
timeFrame: 3 month from enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Kim 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.
citation: Zhang 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.
citation: Kim 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.
citation: Lee 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.