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Trial Title:
HRQOL in Locally Advanced Thyroid Carcinoma
NCT ID:
NCT05824312
Condition:
Thyroid Cancer
Tyrosine Kinase Inhibitor
Health Related Quality of Life
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Tyrosine Kinase Inhibitors
Conditions: Keywords:
HRQOL
thyroid cancer
targeted therapy
Tyrosine kinase inhibitor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Tyrosine kinase inhibitor drugs.
Description:
TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.
Arm group label:
TKI group
Other name:
TKI treatment
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.).
Detailed description:
Surgical resection is the cornerstone of treatment for thyroid cancer. However, some
patients present with locally advanced disease at the time of diagnosis, and they are not
eligible for radical resection. Another patients still had the risk of recurrence after
surgery, endocrine therapy and iodine-131 treatment. Tyrosine kinase inhibitors (TKI)
have been proved to be effective in thyroid cancer patients. However, it was still
unclear whether TKI drugs had influence on the HRQOL of LATC patients. 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.).Participants enroll the study after informed consent, and quality of
life will be assessed using quality of life questionnaires EORTC QLQ C30, and EORTC THY
47 before surgery, and 1,3,6 and 12 months after treatment.
Criteria for eligibility:
Study pop:
locally advanced thyroid cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients age (18-70 year old)
- Diagnosis of locally advanced thyroid cancer
- Patient receiving TKI drugs.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Locations:
Facility:
Name:
Road Fuma No.420
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
yu wu, doctor
Phone:
13705003480
Email:
dr_wuyu@fjzlhospital.com
Contact backup:
Last name:
jianhong yu, doctor
Phone:
13625090132
Email:
yujianhong@pku.org.cn
Start date:
February 1, 2023
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05824312
