Differentiated Thyroid Cancer
Conditions
Keywords
Differentiated Thyroid Cancer
Brief summary
* 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
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
Interventions
None listed
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
West China Hospital
First Affiliated Hospital of Kunming Medical University
Sir Run Run Shaw Hospital
China-Japan Union Hospital, Jilin University
Chinese PLA General Hospital
Tongji Hospital
First Hospital of China Medical University
Gansu Cancer Hospital
Huazhong University of Science and Technology
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence rate | five year | Five-year accumulated recurrence rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | five year | Evaluated from the date of first-time thyroidectomy to the death for any reason |
| Response to therapy | five year | Presented by number of patients and proportions |
| Re-operation rate | five year | the percentage of patients accepting operation due to DTC progression. |
| Disease-free survival (DFS) | five year | Evaluated from the date of first-time thyroidectomy to the first to the progression date or death related to disease progression, whichever occurs first |
| Adverse events related to L-T4 therapy (ADRs) | five year | The number of patients, number of ADRs and the incidence rate will be summarized for L-T4 therapy |
| Median follow-up years | five year | Gained by statistical summary of median follow-up time |
| Time weighted TSH level (TW-TSH) | five year | Calculated by specific formula |
Countries
China
Contacts
Primary ContactJie Ming, M.D.
Backup ContactTao Huang, M.D.
Outcome results
None listed