Iodine Nutrition Status and Clinical Characteristics of Thyroid Cancer
ConditionThyroid Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorShandong Provincial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Iodine excess
Dietary supplementIodine excess areas: water iodine ≥100μg/L; or urinary iodine concentration (median urinary iodine levels in children aged 8-10 years old)≥300μg/L
Iodine suitable
Dietary supplementIodine 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.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Excessive iodine group1 intervention
Group B: Suitable iodine group1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with recurrence
Recurrence: diagnosed as the same type of thyroid cancer again by pathology
Time frame
from enrollment to the final follow-up at 5 years2
Number of participants with distant metastasis
Distant metastasis: Pathological confirmed thyroid cancer occurring outside the thyroid gland
Time frame
from enrollment to the final follow-up at 5 years3
All-cause mortality
The ratio of the total number of deaths caused by various reasons during the research period to the number of participants
Time frame
from enrollment to the final follow-up at 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov