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

NCT04857086 | Unknown DMC

• 1 other identifier: MS200007_0003
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 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 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

Conditions

Differentiated Thyroid Cancer

Keywords

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• recurrence rate

  Five-year accumulated recurrence rate

  five year

Secondary Outcomes (7)

• Disease-free survival (DFS)

  five year

• Overall survival (OS)

  five year

• Response to therapy

  five year

• Re-operation rate

  five year

• Time weighted TSH level (TW-TSH)

  five year

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Central Study Contacts

Jie Ming, M.D.

CONTACT

8610 02785351622; mingjiewh@126.com

Tao Huang, M.D.

CONTACT

8610 02785351622; huangtaowh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• 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: April 20, 2021
• First Posted: April 23, 2021
• Study Start: December 30, 2020
• Primary Completion: July 30, 2022
• Study Completion: March 28, 2023
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)