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Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients.

Primary Purpose

Thyroid Cancer, Papillary, Hypothyroidism

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
L-T4
L-T4+T3 (thyroid tablet)
Sponsored by
Zhongshan Hospital Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer, Papillary focused on measuring type 2 deiodinase, TSH suppression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-65
  2. Patients with Hypothyroidism after total thyroidectomy for papillary thyroid carcinoma
  3. Patients were informed of the study and voluntarily willing to participate.

Exclusion Criteria:

  1. Having depression or other mental illness
  2. Taking drugs that interfere with thyroid hormone absorption for other chronic diseases
  3. impaired liver function, defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
  4. impaired renal function ,eGFR: <45 mL/min (calculated by MDRD formula)
  5. 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

Sites / Locations

  • Yan LingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

L-T4 therapy group

L-T4+T3 therapy group

Arm Description

Patients with refractory hypothyroidism still receive L-T4 therapy as usual.

Patients with refractory hypothyroidism receive L-T4+T3 therapy

Outcomes

Primary Outcome Measures

TSH suppression
The TSH level can reach the aim of the TSH suppresion therapy

Secondary Outcome Measures

quality life evalutaion
evaluate the quality life of the patients with SF-36 survey.

Full Information

First Posted
February 9, 2022
Last Updated
February 9, 2022
Sponsor
Zhongshan Hospital Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT05247476
Brief Title
Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients.
Official Title
Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Hospital Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Papillary, Hypothyroidism
Keywords
type 2 deiodinase, TSH suppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-T4 therapy group
Arm Type
Active Comparator
Arm Description
Patients with refractory hypothyroidism still receive L-T4 therapy as usual.
Arm Title
L-T4+T3 therapy group
Arm Type
Experimental
Arm Description
Patients with refractory hypothyroidism receive L-T4+T3 therapy
Intervention Type
Drug
Intervention Name(s)
L-T4
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
L-T4+T3 (thyroid tablet)
Intervention Description
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.
Primary Outcome Measure Information:
Title
TSH suppression
Description
The TSH level can reach the aim of the TSH suppresion therapy
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
quality life evalutaion
Description
evaluate the quality life of the patients with SF-36 survey.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Patients with Hypothyroidism after total thyroidectomy for papillary thyroid carcinoma Patients were informed of the study and voluntarily willing to participate. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanling Huang, principal
Phone
+8615880277690
Email
xmhuangyanling@xmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Junhan Chen, assistant
Phone
15280406008
Email
116569145@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yilin Zhao
Organizational Affiliation
Zhongshan Hospital Xiamen University
Official's Role
Study Director
Facility Information:
Facility Name
Yan Ling
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yan ling
Phone
13850087896
Email
1543820053@qq.com
First Name & Middle Initial & Last Name & Degree
Junhan Chen
Phone
15280406008
Email
116569145@qq.com

12. IPD Sharing Statement

Learn more about this trial

Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients.

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