Differentiated Thyroid CancerNCT04857086
The 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 five 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
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2020to 28 Mar 2023
- 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: The patients are those who had been recruited into the first stage of DTCC study, including intermediate and high risk DTC patients.
Who may be able to join
- Patients who had been recruited into DTCC 1st study will be enrolled.
Who cannot join
- Other malignant tumors;
- Severe organ damage such as heart failure of New York Heart Association classes III-IV, liver failure, respiratory failure, renal failure, etc.;
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent; ④ Legal incapacity or limited legal capacity; ⑤ 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
Ming Jie, M.D.
About this study
Official title: A Multi-center Study to Observe Five-year Outcomes of the Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China (The Second Stage of DTCC)
- 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 five year follow-up
- To assess response to initial therapy in patients who undergo total or neartotal thyroidectomy and RAI remnant ablation after five year follow-up (according to an modified dynamic risk stratification system)
- To observe the recurrence status after five year follow-up
Read the detailed description
The DTCC 2nd will follow DTCC 1st and observe the long-term efficacy of initial management including surgery treatment, 131I therapy and TSH suppression therapy. It will involve nine hospitals which have participated in the first stage, and continually to observe the DTC patients who were recruited. The patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. For those follow-up less than 5 years, in addition to the retrospective data collection, one prospective visit will be conducted.
Primary endpoint(s)
1.Five-year accumulated recurrence rate
Secondary endpoint(s)
- Disease-free survival (DFS)
- Overall survival (OS)
- Response to therapy
- Re-operation rate
- Time weighted TSH level (TW-TSH)
- Adverse events related to L-T4 therapy (ADRs)
- Median follow-up years
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Differentiated Thyroid Cancer
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 |
|---|---|---|
| Group1 | About 1400 DTC patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Five-year accumulated recurrence rate
Measured: five year
Secondary outcomes (7)
Disease-free survival (DFS)
Evaluated from the date of first-time thyroidectomy to the first to the progression date or death related to disease progression, whichever occurs first
Measured: five year
Overall survival (OS)
Evaluated from the date of first-time thyroidectomy to the death for any reason
Measured: five year
Response to therapy
Presented by number of patients and proportions
Measured: five year
Re-operation rate
the percentage of patients accepting operation due to DTC progression.
Measured: five year
Time weighted TSH level (TW-TSH)
Calculated by specific formula
Measured: five year
Adverse events related to L-T4 therapy (ADRs)
The number of patients, number of ADRs and the incidence rate will be summarized for L-T4 therapy
Measured: five year
Median follow-up years
Gained by statistical summary of median follow-up time
Measured: five year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start30 Dec 2020
- Primary completion30 Jul 2022 (estimated)
- Study completion28 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, First Affiliated Hospital of Kunming Medical University, Sir Run Run Shaw Hospital, China-Japan Union Hospital, Jilin University, Chinese PLA General Hospital, Tongji Hospital, First Hospital of China Medical University, Gansu Cancer Hospital
- Responsible party
- Principal investigator, Tao Huang, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857086
- Sponsor's protocol ID
- MS200007_0003
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study to Observe Five-year Outcomes of the Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China (The Second Stage of DTCC)
- ClinicalTrials.gov ID
- NCT04857086
- Acronym / sponsor ID
- MS200007_0003
- Conditions
- Differentiated Thyroid Cancer
- Keywords
- Differentiated Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, First Affiliated Hospital of Kunming Medical University, Sir Run Run Shaw Hospital, China-Japan Union Hospital, Jilin University, Chinese PLA General Hospital, Tongji Hospital, First Hospital of China Medical University, Gansu Cancer Hospital
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 28 Mar 2023 (estimated)
- First posted
- 23 Apr 2021 (actual)
- 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 five year follow-up
- To assess response to initial therapy in patients who undergo total or neartotal thyroidectomy and RAI remnant ablation after five year follow-up (according to an modified dynamic risk stratification system)
- To observe the recurrence status after five year follow-up
Detailed description
The DTCC 2nd will follow DTCC 1st and observe the long-term efficacy of initial management including surgery treatment, 131I therapy and TSH suppression therapy. It will involve nine hospitals which have participated in the first stage, and continually to observe the DTC patients who were recruited. The patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. For those follow-up less than 5 years, in addition to the retrospective data collection, one prospective visit will be conducted.
Primary endpoint(s)
1.Five-year accumulated recurrence rate
Secondary endpoint(s)
- Disease-free survival (DFS)
- Overall survival (OS)
- Response to therapy
- Re-operation rate
- Time weighted TSH level (TW-TSH)
- Adverse events related to L-T4 therapy (ADRs)
- Median follow-up years
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –About 1400 DTC patients with more than 5 years long-term follow-up from the date of signing the informed consent form (ICF) in DTCC 1st to signing ICF in DTCC 2nd will be collected data retrospectively. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients are those who had been recruited into the first stage of DTCC study, including intermediate and high risk DTC patients.
Key inclusion criteria (1 listed)
- Patients who had been recruited into DTCC 1st study will be enrolled.
Key exclusion criteria (3 listed)
- Other malignant tumors;
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
recurrence rate
Time frame: five year
Five-year accumulated recurrence rate
7 secondary outcomes
Disease-free survival (DFS)
Time frame: five year
Overall survival (OS)
Time frame: five year
Response to therapy
Time frame: five year
Re-operation rate
Time frame: five year
Time weighted TSH level (TW-TSH)
Time frame: five year
Adverse events related to L-T4 therapy (ADRs)
Time frame: five year
Median follow-up years
Time frame: five year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- 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 1 inclusion and 3 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 23 Apr 2021. 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, M.D. (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?
recurrence rate (time frame: five year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.