Differentiated Thyroid CancerDTCCNCT02638077
Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China
An observational study of Differentiated Thyroid Cancer, run by Huazhong University of Science and Technology at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Differentiated Thyroid Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Differentiated Thyroid Cancer patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Jie Ming, 8610 027 85351622, mingjiewh@126.com
About this study
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)
- 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
Read the 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):
- 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
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Differentiated Thyroid Cancer, the initial management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who underwent total/near-total thyroidectomy
Measured: one year
2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy
Measured: one year
Proportion of patients who achieved serum TSH target value
Measured: one year
4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy
Measured: one year
Secondary outcomes (6)
Time to achieve serum TSH target value
Measured: one year
Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value
Measured: one year
3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value
Measured: 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
Measured: one year
Recurrence rate after one year follow-up
Measured: one year
AEs related to L-T4 (or thyroid tablet)treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, First Affiliated Hospital of Kunming Medical University, Sir Run Run Shaw Hospital, Jilin University, Chinese PLA General Hospital, Gansu Cancer Hospital, Tongji Hospital, First Hospital of China Medical University
- Responsible party
- Principal investigator, Tao Huang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638077
- Sponsor's protocol ID
- EMR200125_621
- Acronym
- DTCC
- Status last verified
- Dec 2015
- First submitted
- 18 Dec 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Not yet
Publications
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). 2026 Mar;104(3):255-269. doi: 10.1111/cen.70046. Epub 2025 Oct 16.
PubMed 41102848
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02638077
- Acronym / sponsor ID
- DTCC / EMR200125_621
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Differentiated Thyroid Cancer, the initial management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- West China Hospital, First Affiliated Hospital of Kunming Medical University, Sir Run Run Shaw Hospital, Jilin University, Chinese PLA General Hospital, Gansu Cancer Hospital, Tongji Hospital, First Hospital of China Medical University
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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):
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Differentiated Thyroid Cancer patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Derived from this study: PubMed 41102848Li 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). 2026 Mar;104(3):255-269. doi: 10.1111/cen.70046. Epub 2025 Oct 16.
- Individual participant dataSharing planned: No. Not yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Cancer, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Ming, Doctor of Medicine (8610 02785351622, mingjiewh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who underwent total/near-total thyroidectomy (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02638077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.