Iodine Nutrition Status and Clinical Characteristics of Thyroid Cancer

NCT06623500 | Recruiting

• 1 other identifier: ShandongPH 20240902
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of iodine nutritional status on thyroid cancer has been controversial for many years. We designed a prospective cohort study that recruiting patients in different iodine areas who underwent thyroid cancer surgery in branch hospitals from 2012 to 2019，and follow up their clinical outcomes. We aimed to analyse the relationship between regional iodine nutrition level and pathological types, clinical features, and prognosis of thyroid cancer.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants with recurrence

  Recurrence: diagnosed as the same type of thyroid cancer again by pathology

  from enrollment to the final follow-up at 5 years

• Number of participants with distant metastasis

  Distant metastasis: Pathological confirmed thyroid cancer occurring outside the thyroid gland

  from enrollment to the final follow-up at 5 years

• All-cause mortality

  The ratio of the total number of deaths caused by various reasons during the research period to the number of participants

  from enrollment to the final follow-up at 5 years

Study Arms (2)

Excessive iodine group

Residents with thyroid cancer who have lived in high iodine areas for a long time (5 years or more). According to the report of Shandong Institute 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 thyroid cancer who have lived in suitable iodine areas for a long time (5 years or more). According to the report of Shandong Institute of Endemic Disease Prevention and Control, three sub centers were selected in suitable iodine (Jinan/Shenyang/Haerbin) areas.

Dietary Supplement: Iodine suitable

Interventions

Iodine excess DIETARY_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 suitable DIETARY_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

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Three sub centers were selected in high iodine (Jining/Liaocheng/Heze) and moderate iodine (Jinan/Shenyang/Haerbin) areas respectively. Patients lived in the above-mentioned regions at least for 5 years who was diagnosed as thyroid cancer and underwent thyroid surgery in branch hospitals from 2012 to 2019 were recruited.

You may qualify if:

• Age range: 18\~65 years old, gender not limited;
• Living in the selected region for at least 5 years;
• Patients who underwent thyroid surgery at various research centers were pathologically diagnosed with thyroid cancer;
• The clinical data （general information、surgical scope 、pathological report、utrasonic report, etc ）of the case is complete.

You may not qualify if:

• Diagnosed as other types of cancer or thyroid metastatic cancer;
• There are serious comorbidities such as heart, liver, and kidney diseases present;
• Unable to follow up on prognostic information.

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Qingling Guo

CONTACT

+86 0531-68776375; guoqinglingqhb@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 2, 2024
• Study Start: January 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)