NCT05247476

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 9, 2022

Last Update Submit

February 9, 2022

Conditions

Thyroid Cancer, PapillaryHypothyroidism

Keywords

type 2 deiodinase, TSH suppression

Outcome Measures

Primary Outcomes (1)

  • TSH suppression

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

    Up to 6 months

Secondary Outcomes (1)

  • quality life evalutaion

    Up to 6 months

Study Arms (2)

L-T4 therapy group

ACTIVE COMPARATOR

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

Drug: L-T4

L-T4+T3 therapy group

EXPERIMENTAL

Patients with refractory hypothyroidism receive L-T4+T3 therapy

Drug: L-T4+T3 (thyroid tablet)

Interventions

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 therapy group
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.

L-T4+T3 therapy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • \. Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yan Ling

Xiamen, Fujian, 361004, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, PapillaryHypothyroidism

Interventions

Thyroid (USP)

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Yilin Zhao

    Zhongshan Hospital Xiamen University

    STUDY DIRECTOR

Central Study Contacts

Yanling Huang, principal

CONTACT

+8615880277690xmhuangyanling@xmu.edu.cn

Junhan Chen, assistant

CONTACT

15280406008116569145@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

October 18, 2021

Primary Completion

March 1, 2022

Study Completion

September 1, 2022

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

CN(1)