Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China
DTCC
A Multi-center, Prospective Study to Observe the Initial Management of Patients With Differentiated Thyroid Cancer in the Real World in China (DTCC Study)
1 other identifier
observational
2,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedDecember 22, 2015
December 1, 2015
1.5 years
December 18, 2015
December 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of patients who underwent total/near-total thyroidectomy
one year
2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy
one year
Proportion of patients who achieved serum TSH target value
one year
4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy
one year
Secondary Outcomes (6)
Time to achieve serum TSH target value
one year
Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value
one year
3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value
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
one year
Recurrence rate after one year follow-up
one year
- +1 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Differentiated Thyroid Cancer patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huazhong University of Science and Technologylead
- West China Hospitalcollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Jilin Universitycollaborator
- Chinese PLA General Hospitalcollaborator
- Gansu Cancer Hospitalcollaborator
- Tongji Hospitalcollaborator
- First Hospital of China Medical Universitycollaborator
Study Sites (1)
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Related Publications (1)
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.
PMID: 41102848DERIVED
Biospecimen
tumors samples will retained for detecting gene mutation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of breast and thyroid department of Wuhan Union Hospital, Tongji Medical College
Study Record Dates
First Submitted
December 18, 2015
First Posted
December 22, 2015
Study Start
October 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
December 22, 2015
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share
Not yet