The Initial Management in Patients With Differentiated Th... | NCT04857086

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

NCT04857086

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Apr 23, 2021Actual

Enrollment

1,400Estimated

Phase

Not provided

Conditions

Differentiated Thyroid Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2020Actual

Primary Completion Date

Jul 30, 2022Estimated

Completion Date

Mar 28, 2023Estimated

First Submitted Date

Apr 20, 2021

First Submission Date that Met QC Criteria

Apr 20, 2021

First Posted Date

Apr 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2021

Last Update Posted Date

Apr 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tao Huang, Director of breast and thyroid department of Wuhan Union Hospital，Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	OTHER
West China Hospital	OTHER
First Affiliated Hospital of Kunming Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jie Ming, M.D.	Contact	8610 02785351622		mingjiewh@126.com
Tao Huang, M.D.	Contact	8610 02785351622		huangtaowh@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided