NCT06626581

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

September 25, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 4, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 25, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

iodine statuspapillary thyroid carcinoma

Outcome Measures

Primary Outcomes (2)

  • Serum and urine iodine levels

    1 year from enrollment

  • TNM staging of papillary thyroid cancer

    3 month from enrollment

Study Arms (2)

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).

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).

Dietary Supplement: Iodine suitable

Interventions

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

Excessive iodine group
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.

Suitable iodine group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 34154044BACKGROUND
  • 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.

    PMID: 28258306BACKGROUND
  • 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.

    PMID: 36387866BACKGROUND
  • 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.

    PMID: 34376043BACKGROUND
  • 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.

    PMID: 28513893BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Collect thyroid surgery specimens, serum, and urine from patients

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

September 25, 2024

First Posted

October 4, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share