- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648399
Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma
January 6, 2016 updated by: wenxin zhao, Fujian Medical University
This study recruit the patients with unilateral papillary thyroid cancer before operation,the patients agree to enter the test,and divided into experimental and control group.experimental group patients receive the surgery including unilateral thyroid lobectomy and bilateral central lymph node dissection.and
control group receive the surgery including unilateral thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic lymph node,and numbers of participants with adverse events related to treatment between two groups in order to evaluate the significance of bilateral lymph node dissection.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: wenxin zhao, doctor
- Phone Number: 08613365910359
- Email: fzhzwx6688@163.com
Study Contact Backup
- Name: shouyi yan, master
- Phone Number: 0861598230279
- Email: yansy1985@163.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350000
- Recruiting
- Fujian Medical University Union Hospital
-
Contact:
- wenxin zhao, doctor
- Phone Number: 08613365910359
- Email: fzhzwx6688@163.com
-
Contact:
- shouyi yan, master
- Phone Number: 08615980230279
- Email: yansy1985@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
according by thyroid carcinoma TNM(tumor,lymph node, metastasis) staging of NCCN (National Comprehensive Cancer Network)
Inclusion Criteria:
- 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1~2N0M0
Exclusion Criteria:
- 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
only unilateral center lymph node dissection
|
Other Names:
|
Experimental: experimental group
bilateral center lymph node dissection
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor recurrence
Time Frame: 5 years
|
numbers of patients with tumor recurrence
|
5 years
|
numbers of metastatic lymph node
Time Frame: 1 years
|
numbers of metastatic lymph node
|
1 years
|
adverse events related to treatment
Time Frame: 1 years
|
numbers of participants with adverse events including recurrent nerve injury,parathyroid injury,hemorrhage
|
1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relations between the lymph metastasis and TNM staging
Time Frame: 1 years
|
Coefficient R (SPSS software for correlation analysis)
|
1 years
|
relations between the lymph metastasis and tumor location
Time Frame: 1 years
|
Coefficient R (SPSS software for correlation analysis)
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: wenxin zhao, doctor, Fujian Medical University Union Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
December 13, 2015
First Submitted That Met QC Criteria
January 6, 2016
First Posted (Estimate)
January 7, 2016
Study Record Updates
Last Update Posted (Estimate)
January 7, 2016
Last Update Submitted That Met QC Criteria
January 6, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Adenocarcinoma, Papillary
- Thyroid Neoplasms
- Carcinoma
- Thyroid Diseases
- Thyroid Cancer, Papillary
- Carcinoma, Papillary
Other Study ID Numbers
- wzhao
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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