Thyroid CancerNCT06623500
Iodine Nutrition Status and Clinical Characteristics of Thyroid Cancer
An observational study of Thyroid Cancer, run by Shandong Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Iodine excess and Iodine suitable
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Qingling Guo, doctor, 13026575201, guoqinglingqhb@163.com
Haiqing Zhang, doctor, （86）15168888303, 15168888303@163.com
About this study
Official title: Prospective Cohort Study on Clinical Characteristics of Thyroid Cancer in Different Iodine Status Areas
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.
Read the detailed description
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 for at least 5 years and diagnosed as thyroid cancer and underwent thyroid surgery in branch hospitals from 2012 to 2019 were recruited.
- Conditions
- Thyroid Cancer
- Being tested
- Iodine excess, Iodine suitable
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: Iodine suitable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrence
Recurrence: diagnosed as the same type of thyroid cancer again by pathology
Measured: 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
Measured: 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
Measured: from enrollment to the final follow-up at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Jan 2012
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hai-qing Zhang, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623500
- Sponsor's protocol ID
- ShandongPH 20240902
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Clinical Characteristics of Thyroid Cancer in Different Iodine Status Areas
- ClinicalTrials.gov ID
- NCT06623500
- Acronym / sponsor ID
- ShandongPH 20240902
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 for at least 5 years and diagnosed as thyroid cancer and underwent thyroid surgery in branch hospitals from 2012 to 2019 were recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excessive iodine group | – | Dietary Supplement: Iodine excessResidents 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). |
| Suitable iodine group | – | Dietary Supplement: Iodine suitableResidents 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine excessIodine excess areas: water iodine ≥100μg/L; or urinary iodine concentration (median urinary iodine levels in children aged 8-10 years old)≥300μg/L | Dietary supplement | Excessive iodine group |
| Iodine suitableIodine 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. | Dietary supplement | Suitable iodine group |
Primary outcome
Number of participants with recurrence
Time frame: from enrollment to the final follow-up at 5 years
Recurrence: diagnosed as the same type of thyroid cancer again by pathology
Number of participants with distant metastasis
Time frame: from enrollment to the final follow-up at 5 years
Distant metastasis: Pathological confirmed thyroid cancer occurring outside the thyroid gland
All-cause mortality
Time frame: from enrollment to the final follow-up at 5 years
The ratio of the total number of deaths caused by various reasons during the research period to the number of participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingling Guo (+86 0531-68776375, guoqinglingqhb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recurrence (time frame: from enrollment to the final follow-up at 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.