The Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China

Study Overview
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Brief Summary
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To find out the gap between real-world clinical practice and guideline recommendations in initial management of DTC patients To observe the characteristics of patients who achieved and did not achieve TSH target value after five year follow-up To assess response to initial therapy in patients who undergo total or neartotal thyroidectomy and RAI remnant ablation after five year follow-up (according to an modified dynamic risk stratification system) To observe the recurrence status after five year follow-up

Detailed Description
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The DTCC 2nd will follow DTCC 1st and observe the long-term efficacy of initial management including surgery treatment, 131I therapy and TSH suppression therapy. It will involve nine hospitals which have participated in the first stage, and continually to observe the DTC patients who were recruited. The patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. For those follow-up less than 5 years, in addition to the retrospective data collection, one prospective visit will be conducted. Primary endpoint(s) 1.Five-year accumulated recurrence rate Secondary endpoint(s) Disease-free survival (DFS) Overall survival (OS) Response to therapy Re-operation rate Time weighted TSH level (TW-TSH) Adverse events related to L-T4 therapy (ADRs) Median follow-up years

Official Title
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A Multi-center Study to Observe Five-year Outcomes of the Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China (The Second Stage of DTCC)

Conditions
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Differentiated Thyroid Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients who had been recruited into DTCC 1st study will be enrolled. Exclusion Criteria: Other malignant tumors; Severe organ damage such as heart failure of New York Heart Association classes III-IV, liver failure, respiratory failure, renal failure, etc.; Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent; ④ Legal incapacity or limited legal capacity; ⑤ Unwilling to be followed up
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br>About 1400 DTC patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | Five-year accumulated recurrence rate | five year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) | Evaluated from the date of first-time thyroidectomy to the first to the progression date or death related to disease progression, whichever occurs first | five year | 
| Overall survival (OS) | Evaluated from the date of first-time thyroidectomy to the death for any reason | five year | 
| Response to therapy | Presented by number of patients and proportions | five year | 
| Re-operation rate | the percentage of patients accepting operation due to DTC progression. | five year | 
| Time weighted TSH level (TW-TSH) | Calculated by specific formula | five year | 
| Adverse events related to L-T4 therapy (ADRs) | The number of patients, number of ADRs and the incidence rate will be summarized for L-T4 therapy | five year | 
| Median follow-up years | Gained by statistical summary of median follow-up time | five year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Differentiated Thyroid Cancer