Thyroid Cancer, PapillaryPhase 4NCT05247476
Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients.
A Phase 4 study testing L-T4 and L-T4+T3 (thyroid tablet) in people with Thyroid Cancer, Papillary and Hypothyroidism, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial summary
This project analyzes the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, and explored the factors influencing TSH inhibitory treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Papillary, Hypothyroidism
- What is being tested?
- L-T4 and L-T4+T3 (thyroid tablet)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Patients with Hypothyroidism after total thyroidectomy for papillary thyroid carcinoma
- Patients were informed of the study and voluntarily willing to participate.
Who cannot join
- Having depression or other mental illness
- Taking drugs that interfere with thyroid hormone absorption for other chronic diseases
- impaired liver function, defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- impaired renal function ,eGFR: <45 mL/min (calculated by MDRD formula)
- Recent Cardiovascular Events in a patient:
- (1)Acute Coronary Syndrome (ACS) within 2 months prior to enrolment (2).Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment (3)Acute Stroke or TIA within two months prior to enrolment (4)Less than two months post coronary artery revascularization 6. Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
- 7. Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yan Ling
Xiamen, Fujian, 361004
yan ling, 13850087896, 1543820053@qq.com
Junhan Chen, 15280406008, 116569145@qq.com
About this study
Official title: Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused
This project analyzes the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, and explored the factors influencing TSH inhibitory treatment efficacy. It further explores whether patients with diO2-Thr92ALA genotype or DIO2 Orfa-Gly3ASP genotype should choose T4+T3 treatment, and the effect of different treatment options on the quality life of patients.
Read the detailed description
Object: To explore the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, And figure out if it is better for patients with diO2-Thr92ALA genotype or DIO2 Orfa-Gly3ASP genotype to choose T4+T3 treatment,
Design:
Part I: Analysis of the correlation between DIO2 genotype and TSH inhibitory treatment effect:
- In accordance with inclusion and exclusion criteria; A total of 100 patients undergoing total thyroidectomy for thyroid cancer and 100 patients receiving 131 iodine treatment after total thyroidectomy will be included in our hospital from October 2021 to October 2022. All the patients signed informed consent
- Detection of basic condition: The included patients were recorded with height, weight, BMI, routine biochemistry, homocysteine, thyroid function, thyroid peroxidase antibodies, thyroglobulin, thyroid globulin,
- Genotype detection of DIO2 gene RS225014 and RS12885300 loci were tested for all the patients.
- Regular L-T4 treatment and drug dose adjustment: Patients included in the study were treated with L-T4 daily and the drug dose was adjusted so that FT4 did not exceed the normal range, and the TSH inhibition target was achieved as far as possible. After 3 months' treatment. The data of height, weight, BMI, routine biochemistry, thyroid function, thyroid peroxidase antibodies, thyroglobulin, thyroid globulin were tested again. SF-36 health survey were tested to evaluated the living quality.
- The effect of genotype and allele frequency on TSH inhibitory treatment was analyzed.
Part II: Compare the effects of single L-T4 treatment and L-T4+T3 on TSH inhibitory treatment and side effects
- L-t4 treatment vs T4+T3 treatment: Through the analysis of the first step, patients with refractory hypothyroidism whose FT4 dose reached 1.9ug/kg/d and TSH inhibition treatment failed to reach the standard were screened out, and these patients were randomly divided into L-T4 treatment group and L-T4+T3 treatment group. The patients were followed up for half a year, and the drug dose was adjusted every month to make TSH inhibition treatment target as far as possible.
- After half a year of treatment, the height, weight, BMI, routine biochemistry, thyroid function, thyroid peroxidase antibody, thyroglobulin, thyroglobulin antibody, were examined again. All patients were reevaluated SF-36 health survey.
- Statistical analysis was made of the effects of different treatment methods on TSH inhibition therapy and the effects on patients' quality of life,
- Conditions
- Thyroid Cancer, Papillary, Hypothyroidism
- Being tested
- L-T4, L-T4+T3 (thyroid tablet)
- Keywords
- type 2 deiodinase, TSH suppression
- Medical subject headings
- Thyroid Cancer, Papillary, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-T4Drug
Patients with refractory hypothyroidism continued to receive L-T4 therapy. The drug dose was adjusted so that FT4 did not exceed the normal range, and the TSH suppression target was achieved as far as possible.
L-T4+T3 (thyroid tablet)Drug
Patients with refractory hypothyroidism changed to receive L-T4 +T3 therapy. The drug dose was adjusted so that FT4 did not exceed the normal range, and the TSH suppression target was achieved as far as possible.
| Study group | Role | What they receive |
|---|---|---|
| L-T4 therapy group | Active comparator | Patients with refractory hypothyroidism still receive L-T4 therapy as usual. Receives: Drug: L-T4 |
| L-T4+T3 therapy group | Experimental | Patients with refractory hypothyroidism receive L-T4+T3 therapy Receives: Drug: L-T4+T3 (thyroid tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSH suppression
The TSH level can reach the aim of the TSH suppresion therapy
Measured: Up to 6 months
Secondary outcomes (1)
quality life evalutaion
evaluate the quality life of the patients with SF-36 survey.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start18 Oct 2021
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Cancer, PapillaryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yilin Zhao, Study director, Zhongshan Hospital Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247476
- Sponsor's protocol ID
- 2021-123
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused
- ClinicalTrials.gov ID
- NCT05247476
- Acronym / sponsor ID
- 2021-123
- Conditions
- Thyroid Cancer, Papillary, Hypothyroidism
- Keywords
- type 2 deiodinase, TSH suppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 18 Feb 2022 (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.
This project analyzes the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, and explored the factors influencing TSH inhibitory treatment efficacy. It further explores whether patients with diO2-Thr92ALA genotype or DIO2 Orfa-Gly3ASP genotype should choose T4+T3 treatment, and the effect of different treatment options on the quality life of patients.
Detailed description
Object: To explore the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, And figure out if it is better for patients with diO2-Thr92ALA genotype or DIO2 Orfa-Gly3ASP genotype to choose T4+T3 treatment,
Design:
Part I: Analysis of the correlation between DIO2 genotype and TSH inhibitory treatment effect:
- In accordance with inclusion and exclusion criteria; A total of 100 patients undergoing total thyroidectomy for thyroid cancer and 100 patients receiving 131 iodine treatment after total thyroidectomy will be included in our hospital from October 2021 to October 2022. All the patients signed informed consent
- Detection of basic condition: The included patients were recorded with height, weight, BMI, routine biochemistry, homocysteine, thyroid function, thyroid peroxidase antibodies, thyroglobulin, thyroid globulin,
- Genotype detection of DIO2 gene RS225014 and RS12885300 loci were tested for all the patients.
- Regular L-T4 treatment and drug dose adjustment: Patients included in the study were treated with L-T4 daily and the drug dose was adjusted so that FT4 did not exceed the normal range, and the TSH inhibition target was achieved as far as possible. After 3 months' treatment. The data of height, weight, BMI, routine biochemistry, thyroid function, thyroid peroxidase antibodies, thyroglobulin, thyroid globulin were tested again. SF-36 health survey were tested to evaluated the living quality.
- The effect of genotype and allele frequency on TSH inhibitory treatment was analyzed.
Part II: Compare the effects of single L-T4 treatment and L-T4+T3 on TSH inhibitory treatment and side effects
- L-t4 treatment vs T4+T3 treatment: Through the analysis of the first step, patients with refractory hypothyroidism whose FT4 dose reached 1.9ug/kg/d and TSH inhibition treatment failed to reach the standard were screened out, and these patients were randomly divided into L-T4 treatment group and L-T4+T3 treatment group. The patients were followed up for half a year, and the drug dose was adjusted every month to make TSH inhibition treatment target as far as possible.
- After half a year of treatment, the height, weight, BMI, routine biochemistry, thyroid function, thyroid peroxidase antibody, thyroglobulin, thyroglobulin antibody, were examined again. All patients were reevaluated SF-36 health survey.
- Statistical analysis was made of the effects of different treatment methods on TSH inhibition therapy and the effects on patients' quality of life,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-T4 therapy group | Active comparator | Drug: L-T4Patients with refractory hypothyroidism still receive L-T4 therapy as usual. |
| L-T4+T3 therapy group | Experimental | Drug: L-T4+T3 (thyroid tablet)Patients with refractory hypothyroidism receive L-T4+T3 therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65
- Patients with Hypothyroidism after total thyroidectomy for papillary thyroid carcinoma
- Patients were informed of the study and voluntarily willing to participate.
Key exclusion criteria (7 listed)
- Having depression or other mental illness
- Taking drugs that interfere with thyroid hormone absorption for other chronic diseases
- impaired liver function, defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- impaired renal function ,eGFR: <45 mL/min (calculated by MDRD formula)
- Recent Cardiovascular Events in a patient:
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 |
|---|---|---|
| L-T4Patients with refractory hypothyroidism continued to receive L-T4 therapy. The drug dose was adjusted so that FT4 did not exceed the normal range, and the TSH suppression target was achieved as far as possible. | Drug | L-T4 therapy group |
| L-T4+T3 (thyroid tablet)Patients with refractory hypothyroidism changed to receive L-T4 +T3 therapy. The drug dose was adjusted so that FT4 did not exceed the normal range, and the TSH suppression target was achieved as far as possible. | Drug | L-T4+T3 therapy group |
Primary outcome
TSH suppression
Time frame: Up to 6 months
The TSH level can reach the aim of the TSH suppresion therapy
1 secondary outcome
quality life evalutaion
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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. This study is not recruiting at the moment.
Yilin Zhao study director
Zhongshan Hospital Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-T4 and L-T4+T3 (thyroid tablet) in people with Thyroid Cancer, Papillary and Hypothyroidism, run by Zhongshan Hospital Xiamen University 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanling Huang, principal (+8615880277690, xmhuangyanling@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSH suppression (time frame: Up to 6 months). 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 18 Feb 2022.