The Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China

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

Study Overview

• Status: Recruiting
• Conditions: Differentiated Thyroid Cancer

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

• Study Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

• Study Contact: Name: Jie Ming, M.D.; Phone Number: 8610 02785351622; Email: mingjiewh@126.com
• Study Contact Backup: Name: Tao Huang, M.D.; Phone Number: 8610 02785351622; Email: huangtaowh@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
      • Contact: Ming Jie, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate	Five-year accumulated recurrence rate	five year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	five year
Overall survival (OS)	Evaluated from the date of first-time thyroidectomy to the death for any reason	five year
Response to therapy	Presented by number of patients and proportions	five year
Re-operation rate	the percentage of patients accepting operation due to DTC progression.	five year
Time weighted TSH level (TW-TSH)	Calculated by specific formula	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	five year
Median follow-up years	Gained by statistical summary of median follow-up time	five year

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Chinese PLA General Hospital; West China Hospital; Tongji Hospital; Wuhan Union Hospital, China; The First Affiliated Hospital of Kunming Medical College; Sir Run Run Shaw Hospital; First Hospital of China Medical University; China-Japan Union Hospital, Jilin University; Gansu Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): March 28, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Differentiated Thyroid Cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: MS200007_0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No