Thyroid Papillary CarcinomaNCT02648399
Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma
A study testing surgery：BCND（bilateral central lymph node dissection） and surgery：UCND（unilateral central lymph node dissection） in people with Thyroid Papillary Carcinoma, run by Fujian Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Thyroid Papillary Carcinoma
- What is being tested?
- surgery：BCND（bilateral central lymph node dissection） and surgery：UCND（unilateral central lymph node dissection）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1~2N0M0
Who cannot join
- 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
wenxin zhao, doctor, 08613365910359, fzhzwx6688@163.com
shouyi yan, master, 08615980230279, yansy1985@163.com
About this study
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.
- Conditions
- Thyroid Papillary Carcinoma
- Being tested
- surgery：BCND（bilateral central lymph node dissection）, surgery：UCND（unilateral central lymph node dissection）
- Keywords
- thyroid carcinoma, center lymph node dissection
- Medical subject headings
- Thyroid Cancer, Papillary, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery：BCND（bilateral central lymph node dissection）Procedure or surgery
Also called aad another central lymph node dissection
surgery：UCND（unilateral central lymph node dissection）Procedure or surgery
Also called only unilateral central lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | only unilateral center lymph node dissection Receives: Procedure: surgery：UCND（unilateral central lymph node dissection） |
| experimental group | Experimental | bilateral center lymph node dissection Receives: Procedure: surgery：BCND（bilateral central lymph node dissection） |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor recurrence
numbers of patients with tumor recurrence
Measured: 5 years
numbers of metastatic lymph node
numbers of metastatic lymph node
Measured: 1 years
adverse events related to treatment
numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage
Measured: 1 years
Secondary outcomes (2)
relations between the lymph metastasis and TNM staging
Coefficient R (SPSS software for correlation analysis)
Measured: 1 years
relations between the lymph metastasis and tumor location
Coefficient R (SPSS software for correlation analysis)
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Papillary CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wenxin zhao, Fujian Medical University
- Investigators
- wenxin zhao, doctor, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648399
- Sponsor's protocol ID
- wzhao
- Status last verified
- Jan 2016
- First submitted
- 13 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma
- ClinicalTrials.gov ID
- NCT02648399
- Acronym / sponsor ID
- wzhao
- Conditions
- Thyroid Papillary Carcinoma
- Keywords
- thyroid carcinoma, center lymph node dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: surgery：UCND（unilateral central lymph node dissection）only unilateral center lymph node dissection |
| experimental group | Experimental | Procedure: surgery：BCND（bilateral central lymph node dissection）bilateral center lymph node dissection |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1~2N0M0
Key exclusion criteria (1 listed)
- 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery：BCND（bilateral central lymph node dissection）Also: aad another central lymph node dissection | Procedure or surgery | experimental group |
| surgery：UCND（unilateral central lymph node dissection）Also: only unilateral central lymph node dissection | Procedure or surgery | control group |
Primary outcome
tumor recurrence
Time frame: 5 years
numbers of patients with tumor recurrence
numbers of metastatic lymph node
Time frame: 1 years
numbers of metastatic lymph node
adverse events related to treatment
Time frame: 1 years
numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage
2 secondary outcomes
relations between the lymph metastasis and TNM staging
Time frame: 1 years
relations between the lymph metastasis and tumor location
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Individual participant dataSharing planned: No
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Studies on Tumors of the Thyroid
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wenxin zhao, doctor principal investigator
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery：BCND（bilateral central lymph node dissection） and surgery：UCND（unilateral central lymph node dissection） in people with Thyroid Papillary Carcinoma, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wenxin zhao, doctor (08613365910359, fzhzwx6688@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor recurrence (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.