NCT05824312

Brief Summary

The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

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

February 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 28, 2023

Last Update Submit

April 11, 2023

Conditions

Thyroid CancerTyrosine Kinase InhibitorHealth Related Quality of Life

Keywords

HRQOLthyroid cancertargeted therapyTyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • the global status of QLQ C30 questionnaire

    Change in global HRQOL score between baseline and at 12 months after treatment. A change of more than 10% is set as a limit for a significant change

    1 year

Secondary Outcomes (2)

  • Adversed events of TKI.

    1 year

  • Change in fatigue score

    1 year

Study Arms (2)

TKI group

patients with LATC receiving Tyrosine kinase inhibitor drugs.

Drug: Tyrosine kinase inhibitor drugs.

Controlled group

patients with LATC receiving other treatment.

Interventions

Tyrosine kinase inhibitor drugs.DRUG

TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.

Also known as: TKI treatment
TKI group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

locally advanced thyroid cancer

You may qualify if:

  • Patients age (18-70 year old)
  • Diagnosis of locally advanced thyroid cancer
  • Patient receiving TKI drugs.

You may not qualify if:

  • pregnancy or breastfeeding women;
  • history of other malignant diseases, unstable angina, myocardial infarction, cerebral infarction or cerebral hemorrhage within 6 months; (3) patients missing questionnaires greater than 3 times.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Road Fuma No.420

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Hui Liu

    FujianMedical University Cancer Hospital

    STUDY CHAIR

Central Study Contacts

yu wu, doctor

CONTACT

13705003480dr_wuyu@fjzlhospital.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 21, 2023

Study Start

February 1, 2023

Primary Completion

January 31, 2025

Study Completion

January 31, 2026

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)