Clinical trial NCT04857086: The Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Differentiated Thyroid Cancer
Keywords: Differentiated Thyroid Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: West China Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Sir Run Run Shaw Hospital
name: China-Japan Union Hospital, Jilin University
name: Chinese PLA General Hospital
name: Tongji Hospital
name: First Hospital of China Medical University
name: Gansu Cancer Hospital
First posted: 2021-04-23
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients are those who had been recruited into the first stage of DTCC study, including intermediate and high risk DTC patients.

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 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)

1. Disease-free survival (DFS)
2. Overall survival (OS)
3. Response to therapy
4. Re-operation rate
5. Time weighted TSH level (TW-TSH)
6. Adverse events related to L-T4 therapy (ADRs)
7. Median follow-up years

Eligibility criteria: Inclusion Criteria:

- Patients who had been recruited into DTCC 1st study will be enrolled.

Exclusion Criteria:

* 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

Primary outcomes:
measure: recurrence rate
timeFrame: five year
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: five year
measure: Overall survival (OS)
timeFrame: five year
measure: Response to therapy
timeFrame: five year
measure: Re-operation rate
timeFrame: five year
measure: Time weighted TSH level (TW-TSH)
timeFrame: five year
measure: Adverse events related to L-T4 therapy (ADRs)
timeFrame: five year
measure: Median follow-up years
timeFrame: five year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: