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

Differentiated Thyroid Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857086
• Other study ID #: MS200007_0003
• Status: Recruiting
• Start date: December 30, 2020
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2021
• Source: Huazhong University of Science and Technology
• Contact: Jie Ming, M.D.
• Phone: 8610 02785351622
• Email: mingjiewh[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: March 28, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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; ? Legal incapacity or limited legal capacity; ? Unwilling to be followed up

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
China	Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (10)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	China-Japan Union Hospital, Jilin University, Chinese PLA General Hospital, First Hospital of China Medical University, Gansu Cancer Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Kunming Medical College, Tongji Hospital, West China Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

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