Iodine Status and Characteristics of Papillary Thyroid Cancer

October 3, 2024 updated by: Hai-qing Zhang, Shandong Provincial Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Iodine excess areas: water iodine ≥100μg/L; or urinary iodine concentration(median urinary iodine levels in children aged 8-10 years old) ≥300μg/L
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum and urine iodine levels
Time Frame: 1 year from enrollment
1 year from enrollment
TNM staging of papillary thyroid cancer
Time Frame: 3 month from enrollment
3 month from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShandongPH 20240923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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