Thyroid CancerLATCQOLNCT05824312
HRQOL in Locally Advanced Thyroid Carcinoma
An observational study of Thyroid Cancer and Tyrosine Kinase Inhibitor, run by Fujian Cancer Hospital at 1 site in China.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Tyrosine Kinase Inhibitor, Health Related Quality of Life
- What is being tested?
- Tyrosine kinase inhibitor drugs.
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: locally advanced thyroid cancer
Who may be able to join
- Patients age (18-70 year old)
- Diagnosis of locally advanced thyroid cancer
- Patient receiving TKI drugs.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Road Fuma No.420
Fuzhou, Fujian, 350014
yu wu, doctor, 13705003480, dr_wuyu@fjzlhospital.com
jianhong yu, doctor, 13625090132, yujianhong@pku.org.cn
About this study
Official title: Health-related Quality of Life of Patients With Locally Advanced Thyroid Cancer Receiving Targeted Therapy
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.).
Read the 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.
- Being tested
- Tyrosine kinase inhibitor drugs.
- Keywords
- HRQOL, thyroid cancer, targeted therapy, Tyrosine kinase inhibitor
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyrosine kinase inhibitor drugs.Drug
Also called TKI treatment
TKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks.
| Study group | Role | What they receive |
|---|---|---|
| TKI group | patients with LATC receiving Tyrosine kinase inhibitor drugs. Receives: Drug: Tyrosine kinase inhibitor drugs. | |
| Controlled group | patients with LATC receiving other treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Adversed events of TKI.
all TKI-related adversed events during and after the treatment of TKI.
Measured: 1 year
Change in fatigue score
Change in fatigue score between start and at 12 months after thyroid treatment. A change of more than 10% is set as a limit for a significant change.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Feb 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hui Liu, Study chair, FujianMedical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824312
- Sponsor's protocol ID
- FJCH_HNS_QOL01
- Acronym
- LATCQOL
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life of Patients With Locally Advanced Thyroid Cancer Receiving Targeted Therapy
- ClinicalTrials.gov ID
- NCT05824312
- Acronym / sponsor ID
- LATCQOL / FJCH_HNS_QOL01
- Keywords
- HRQOL, thyroid cancer, targeted therapy, Tyrosine kinase inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKI group | – | Drug: Tyrosine kinase inhibitor drugs.patients with LATC receiving Tyrosine kinase inhibitor drugs. |
| Controlled group | – | –patients with LATC receiving other treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- locally advanced thyroid cancer
Key inclusion criteria (3 listed)
- Patients age (18-70 year old)
- Diagnosis of locally advanced thyroid cancer
- Patient receiving TKI drugs.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tyrosine kinase inhibitor drugs.Also: TKI treatmentTKI drugs were used at least 8 weeks. Imaging exam would be taken every four weeks. | Drug | TKI group |
Primary outcome
the global status of QLQ C30 questionnaire
Time frame: 1 year
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
2 secondary outcomes
Adversed events of TKI.
Time frame: 1 year
Change in fatigue score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Liu study chair
FujianMedical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Tyrosine Kinase Inhibitor, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yu wu, doctor (13705003480, dr_wuyu@fjzlhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the global status of QLQ C30 questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.