* 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
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) 1. Disease-free survival (DFS) 2. Overall survival (OS) 3. Response to therapy 4. Re-operation rate 5. Time weighted TSH level (TW-TSH) 6. Adverse events related to L-T4 therapy (ADRs) 7. Median follow-up years
Study Type
OBSERVATIONAL
Enrollment
1,400
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGrecurrence rate
Five-year accumulated recurrence rate
Time frame: five year
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
Time frame: five year
Overall survival (OS)
Evaluated from the date of first-time thyroidectomy to the death for any reason
Time frame: five year
Response to therapy
Presented by number of patients and proportions
Time frame: five year
Re-operation rate
the percentage of patients accepting operation due to DTC progression.
Time frame: five year
Time weighted TSH level (TW-TSH)
Calculated by specific formula
Time frame: 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
Time frame: five year
Median follow-up years
Gained by statistical summary of median follow-up time
Time frame: five year
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