Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China
NCT ID: NCT02638077
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2015-10-31
2017-04-30
Brief Summary
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* 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
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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
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
ALL
No
Sponsors
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West China Hospital
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Sir Run Run Shaw Hospital
OTHER
Jilin University
OTHER
Chinese PLA General Hospital
OTHER
Gansu Cancer Hospital
OTHER
Tongji Hospital
OTHER
First Hospital of China Medical University
OTHER
Huazhong University of Science and Technology
OTHER
Responsible Party
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Tao Huang
Director of breast and thyroid department of Wuhan Union Hospital, Tongji Medical College
Locations
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Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Jie Ming
Role: primary
References
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Li C, Li S, Zhao Y, Zhang D, Fu Y, Zhou L, Li J, Li F, Du R, Liang N, Sun H. Prognostic Value of Hematological Inflammatory Indices (PLR, NLR, SII) in Medium and High-Risk Papillary Thyroid Carcinoma: A Multicenter Cohort Study. Clin Endocrinol (Oxf). 2025 Oct 16. doi: 10.1111/cen.70046. Online ahead of print.
Other Identifiers
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EMR200125_621
Identifier Type: -
Identifier Source: org_study_id