Clinical trial NCT02638077: Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Differentiated Thyroid Cancer
Keywords: Differentiated Thyroid Cancer
the initial management
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Sir Run Run Shaw Hospital
name: Jilin University
name: Chinese PLA General Hospital
name: Gansu Cancer Hospital
name: Tongji Hospital
name: First Hospital of China Medical University
First posted: 2015-12-22
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Differentiated Thyroid Cancer patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited.

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 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who underwent total/near-total thyroidectomy
timeFrame: one year
measure: 2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy
timeFrame: one year
measure: Proportion of patients who achieved serum TSH target value
timeFrame: one year
measure: 4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy
timeFrame: one year
Secondary outcomes:
measure: Time to achieve serum TSH target value
timeFrame: one year
measure: Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value
timeFrame: one year
measure: 3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value
timeFrame: one year
measure: 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
timeFrame: one year
measure: Recurrence rate after one year follow-up
timeFrame: one year
measure: AEs related to L-T4 (or thyroid tablet)treatment
timeFrame: one year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: