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

Differentiated Thyroid Cancer Clinical Trial

Official title: A Multi-center, Prospective Study to Observe the Initial Management of Patients With Differentiated Thyroid Cancer in the Real World in China (DTCC Study)

Status Recruiting

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 one year follow-up

• To assess response to initial therapy in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up (according to an modified dynamic risk stratification system)

• To observe the recurrence status after one year follow-up

Clinical Trial Description

Multi-center, prospective, registry study

2000 DTC patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited. Doctors can treat the patients based on disease conditions. Investigators will record data which are related to study endpoints.

Primary endpoint(s):

1. Proportion of patients who underwent total/near-total thyroidectomy

2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy

3. Proportion of patients who achieved serum TSH target value

4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy

Secondary endpoint(s):

1. Time to achieve serum TSH target value

2. Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value

3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value

4. Proportion of excellent response/Acceptable response/Biochemical incomplete response/Structural incomplete response to initial management in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up

5. Recurrence rate after one year follow-up

6. AEs related to L-T4 (or thyroid tablet)treatment ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

• NCT number: NCT02638077
• Study type: Observational
• Source: Huazhong University of Science and Technology
• Contact: Jie Ming, Doctor of Medicine
• Phone: 8610 02785351622
• Email: mingjiewh@126.com
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Completion date: April 2017