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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Differentiated Thyroid Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04857086

MS200007_0003

Details and patient eligibility

About

• 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

Full 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

Enrollment: 1,400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,400 participants in 1 patient group

Group1

Description:

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.