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Initial Management in Patients With Differentiated Thyroid Cancer in the Real World in China (DTCC)

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ClinicalTrials.gov Identifier: NCT02638077
Recruitment Status : Unknown
Verified December 2015 by Tao Huang, Wuhan Union Hospital, China.
Recruitment status was:  Recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Collaborators:
West China Hospital
The First Affiliated Hospital of Kunming Medical College
Sir Run Run Shaw Hospital
Jilin University
Chinese PLA General Hospital
Gansu Cancer Hospital
Tongji Hospital
First Hospital of China Medical University
Information provided by (Responsible Party):
Tao Huang, Wuhan Union Hospital, China

Study Description
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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 one year follow-up
  • To assess response to initial therapy in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up (according to an modified dynamic risk stratification system)
  • To observe the recurrence status after one year follow-up

Condition or disease
Differentiated Thyroid Cancer

Detailed Description:

Multi-center, prospective, registry study

2000 DTC patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited. Doctors can treat the patients based on disease conditions. Investigators will record data which are related to study endpoints.

Primary endpoint(s):

  1. Proportion of patients who underwent total/near-total thyroidectomy
  2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy
  3. Proportion of patients who achieved serum TSH target value
  4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy

Secondary endpoint(s):

  1. Time to achieve serum TSH target value
  2. Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value
  3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value
  4. Proportion of excellent response/Acceptable response/Biochemical incomplete response/Structural incomplete response to initial management in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up
  5. Recurrence rate after one year follow-up
  6. AEs related to L-T4 (or thyroid tablet)treatment
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Prospective Study to Observe the Initial Management of Patients With Differentiated Thyroid Cancer in the Real World in China (DTCC Study)
Study Start Date : October 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort
Group 1
2000 DTC patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited. Doctors can treat the patients based on disease conditions. Investigators will record data which are related to study endpoints.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients who underwent total/near-total thyroidectomy [ Time Frame: one year ]
  2. 2. Proportion of patients who were treated by 131I after undergoing total/near-total thyroidectomy [ Time Frame: one year ]
  3. Proportion of patients who achieved serum TSH target value [ Time Frame: one year ]
  4. 4. Proportion of patients who did not achieve serum TSH target value although they were treated by TSH suppression therapy [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Time to achieve serum TSH target value [ Time Frame: one year ]
  2. Dosage of L-T4 for patients who achieved and did not achieve serum TSH target value [ Time Frame: one year ]
  3. 3. Dosage of L-T4 per kilogram of body weight for patients who achieved and did not achieve serum TSH target value [ Time Frame: one year ]
  4. 4. Proportion of excellent response/Acceptable response/Biochemical incomplete response/Structural incomplete response to initial management in patients who undergo total or near-total thyroidectomy and RAI remnant ablation after one year follow-up [ Time Frame: one year ]
  5. Recurrence rate after one year follow-up [ Time Frame: one year ]
  6. AEs related to L-T4 (or thyroid tablet)treatment [ Time Frame: one year ]

Biospecimen Retention:   None Retained
tumors samples will retained for detecting gene mutation

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Differentiated Thyroid Cancer patients undergo the first-time thyroidectomy and identified as intermediate or high risk of recurrence will be recruited.
Criteria

Inclusion Criteria:

  1. Patients who are diagnosed as DTC (the diagnosis should base on pre-operative examinations and post-operative pathology report)
  2. Patients who undergo the first-time thyroidectomy
  3. Patients who are identified as intermediate-risk or high-risk of recurrence after thyroidectomy (according to the recurrence risk stratification of Chinese management guideline for patients with thyroid nodules and differentiated thyroid cancer published in 2012)
  4. Patients who have Chinese nationality
  5. Patients who have signed an informed consent form

Exclusion Criteria:

  1. History of thyroid surgery
  2. Other malignant tumors
  3. Severe organ damage such as heart failure of New York Heart Association classes III-IV, liverfailure, respiratory failure, renal failure, etc.
  4. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
  5. Legal incapacity or limited legal capacity
  6. Unwilling to be followed up
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638077


Contacts
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Contact: Jie Ming, Doctor of Medicine 8610 02785351622 mingjiewh@126.com
Contact: Tao Huang, Doctor of Medicine 8610 02785351622 huangtaowh@163.com

Locations
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China, Hubei
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Jie Ming    8610 027 85351622    mingjiewh@126.com   
Sponsors and Collaborators
Huazhong University of Science and Technology
West China Hospital
The First Affiliated Hospital of Kunming Medical College
Sir Run Run Shaw Hospital
Jilin University
Chinese PLA General Hospital
Gansu Cancer Hospital
Tongji Hospital
First Hospital of China Medical University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Tao Huang, Director of breast and thyroid department of Wuhan Union Hospital, Tongji Medical College, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02638077    
Other Study ID Numbers: EMR200125_621
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not yet
Keywords provided by Tao Huang, Wuhan Union Hospital, China:
Differentiated Thyroid Cancer
the initial management
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms