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

Differentiated Thyroid Cancer Clinical Trial

— DTCC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02638077
• Other study ID #: EMR200125_621
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2015
• Last updated: December 18, 2015
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: December 2015
• Source: Huazhong University of Science and Technology
• Contact: Jie Ming, Doctor of Medicine
• Phone: 8610 02785351622
• Email: mingjiewh[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• 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 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients who are diagnosed as DTC (the diagnosis should base on pre-operative examinations and post-operative pathology report)

2. Patients who undergo the first-time thyroidectomy

3. Patients who are identified as intermediate-risk or high-risk of recurrence after thyroidectomy (according to the recurrence risk stratification of Chinese management guideline for patients with thyroid nodules and differentiated thyroid cancer published in 2012)

4. Patients who have Chinese nationality

5. Patients who have signed an informed consent form

Exclusion Criteria:

1. History of thyroid surgery

2. Other malignant tumors

3. Severe organ damage such as heart failure of New York Heart Association classes III-IV, liverfailure, respiratory failure, renal failure, etc.

4. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent

5. Legal incapacity or limited legal capacity

6. Unwilling to be followed up

Study Design

Observational Model: Cohort, Time Perspective: Prospective

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 (9)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who underwent total/near-total thyroidectomy		one year	No
Primary	2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy		one year	No
Primary	Proportion of patients who achieved serum TSH target value		one year	No
Primary	4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy		one year	No
Secondary	Time to achieve serum TSH target value		one year	No
Secondary	Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value		one year	No
Secondary	3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value		one year	No
Secondary	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		one year	No
Secondary	Recurrence rate after one year follow-up		one year	No
Secondary	AEs related to L-T4 (or thyroid tablet)treatment		one year	No