HRQOL in Locally Advanced Thyroid Carcinoma

NCT ID: NCT05824312

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Thyroid Cancer Tyrosine Kinase Inhibitor Health Related Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TKI group

patients with LATC receiving Tyrosine kinase inhibitor drugs.

Tyrosine kinase inhibitor drugs.

Intervention Type DRUG

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

Controlled group

patients with LATC receiving other treatment.

No interventions assigned to this group

Interventions

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Tyrosine kinase inhibitor drugs.

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

Intervention Type DRUG

Other Intervention Names

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TKI treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui Liu

Role: STUDY_CHAIR

FujianMedical University Cancer Hospital

Locations

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Road Fuma No.420

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yu wu, doctor

Role: CONTACT

13705003480

Facility Contacts

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yu wu, doctor

Role: primary

13705003480

jianhong yu, doctor

Role: backup

13625090132

Other Identifiers

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FJCH_HNS_QOL01

Identifier Type: -

Identifier Source: org_study_id

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