Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China (DTCC)
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ClinicalTrials.gov Identifier: NCT02638077 |
Recruitment Status : Unknown
Verified December 2015 by Tao Huang, Wuhan Union Hospital, China.
Recruitment status was: Recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
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- 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
Condition or disease |
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Differentiated Thyroid Cancer |
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):
- Proportion of patients who underwent total/near-total thyroidectomy
- Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy
- Proportion of patients who achieved serum TSH target value
- Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy
Secondary endpoint(s):
- Time to achieve serum TSH target value
- Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value
- Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value
- 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
- Recurrence rate after one year follow-up
- AEs related to L-T4 (or thyroid tablet)treatment
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 Start Date : | October 2015 |
Estimated Primary Completion Date : | April 2017 |
Estimated Study Completion Date : | April 2017 |
Group/Cohort |
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Group 1
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.
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- Proportion of patients who underwent total/near-total thyroidectomy [ Time Frame: one year ]
- 2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy [ Time Frame: one year ]
- Proportion of patients who achieved serum TSH target value [ Time Frame: one year ]
- 4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy [ Time Frame: one year ]
- Time to achieve serum TSH target value [ Time Frame: one year ]
- Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value [ Time Frame: one year ]
- 3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value [ Time Frame: one year ]
- 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 [ Time Frame: one year ]
- Recurrence rate after one year follow-up [ Time Frame: one year ]
- AEs related to L-T4 (or thyroid tablet)treatment [ Time Frame: one year ]
Biospecimen Retention: None Retained

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients who are diagnosed as DTC (the diagnosis should base on pre-operative examinations and post-operative pathology report)
- Patients who undergo the first-time thyroidectomy
- 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)
- Patients who have Chinese nationality
- Patients who have signed an informed consent form
Exclusion Criteria:
- History of thyroid surgery
- Other malignant tumors
- Severe organ damage such as heart failure of New York Heart Association classes III-IV, liverfailure, 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638077
Contact: Jie Ming, Doctor of Medicine | 8610 02785351622 | mingjiewh@126.com | |
Contact: Tao Huang, Doctor of Medicine | 8610 02785351622 | huangtaowh@163.com |
China, Hubei | |
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
Wuhan, Hubei, China, 430022 | |
Contact: Jie Ming 8610 027 85351622 mingjiewh@126.com |
Responsible Party: | Tao Huang, Director of breast and thyroid department of Wuhan Union Hospital, Tongji Medical College, Wuhan Union Hospital, China |
ClinicalTrials.gov Identifier: | NCT02638077 |
Other Study ID Numbers: |
EMR200125_621 |
First Posted: | December 22, 2015 Key Record Dates |
Last Update Posted: | December 22, 2015 |
Last Verified: | December 2015 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Not yet |
Differentiated Thyroid Cancer the initial management |
Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms |