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

• Conditions: Differentiated Thyroid Cancer

• Registration Number: NCT04857086
• Lead Sponsor: Huazhong University of Science and Technology

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

Study Timeline

• Study Start: 2020-12-30
• Status Verified: 2021-04
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Last Update Submitted: 2021-04-20
• Study First Posted: 2021-04-23
• Last Update Posted: 2021-04-23
• Primary Completion: 2022-07-30
• Study Completion: 2023-03-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence rate	five year	Five-year accumulated recurrence rate

Secondary Outcome Measures

Name	Time	Method
Response to therapy	five year	Presented by number of patients and proportions
Median follow-up years	five year	Gained by statistical summary of median follow-up time
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
Overall survival (OS)	five year	Evaluated from the date of first-time thyroidectomy to the death for any reason
Re-operation rate	five year	the percentage of patients accepting operation due to DTC progression.
Time weighted TSH level (TW-TSH)	five year	Calculated by specific formula
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

Trial Locations

Locations (1)

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China