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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033835
Receipt No. R000038589
Scientific Title Clinical characteristics of papillary thyroid carcinoma patients with Delphian lymph node metastasis: a single-institution study, systemic review and meta-analysis
Date of disclosure of the study information 2018/08/21
Last modified on 2018/08/21

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Basic information
Public title Clinical characteristics of papillary thyroid carcinoma patients with Delphian lymph node metastasis: a single-institution study, systemic review and meta-analysis
Acronym Predicting spread to lymph nodes in papillary thyroid cancer patients based on clinical characteristics
Scientific Title Clinical characteristics of papillary thyroid carcinoma patients with Delphian lymph node metastasis: a single-institution study, systemic review and meta-analysis
Scientific Title:Acronym Predicting spread to lymph nodes in papillary thyroid cancer patients based on clinical characteristics
Region
Asia(except Japan)

Condition
Condition thyroid carcinoma and Delphian lymph node metastasis
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the clinicopathological characteristics of papillary thyroid carcinoma patients with Delphian lymph node metastasis
Basic objectives2 Others
Basic objectives -Others To identify the independent risk factors for Delphian lymph node metastasis and the ability of Delphian lymph node metastasis to predict further central lymph node metastasis and lateral lymph node metastasis
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical characteristics of Delphian lymph node metastasis in thyroid carcinoma was evaluated from 2017 to 2018.
Key secondary outcomes Independent risk factors for DLN metastasis, assessed through multivariate analysis of significant factors.
Ability of DLN metastasis to predict further central lymph node metastasis and lateral lymph node metastasis, assessed through reviewing central and lateral lymph node metastasis

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Total thyroidectomy or ipsilateral thyroidectomy with central lymph node dissection
2. Aged 18-70
3. Preoperatively diagnosed with micropapillary carcinoma, based on ultrasound-guided fine needle aspiration cytology
4. Signed informed consent
Key exclusion criteria 1. Contraindications for anaesthesia (e.g. pregnancy, multiple organ failure, mental illness)
2. History of neck surgery or radiotherapy
3. Inability to comply with follow-up protocol
Target sample size 146

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ming Qiu
Organization Changzheng Hospital affliated Second Military Medical University
Division name Shanghai
Zip code
Address No. 415 in Fengyang Road in Huangpu District
TEL 86-21-81885801
Email qium127@smmu.edu.cn

Public contact
Name of contact person
1st name
Middle name
Last name Ming Qiu
Organization Changzheng Hospital affliated Second Military Medical University
Division name Shanghai
Zip code
Address No. 415 in Fengyang Road in Huangpu District
TEL 86-21-81885801
Homepage URL
Email qium127@smmu.edu.cn

Sponsor
Institute Changzheng Hospital
General surgery department
Institute
Department

Funding Source
Organization the National Natural Science Foundation of China
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization China

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Changzheng Hospital affliated Second Military Medical University

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In own series, Delphian lymph node metastasis was detected in 12 (8.2%) of 146 papillary thyroid carcinoma patients and was significantly associated with tumor size >1cm (P=0.029) and extrathyroid extension (P=0.002) in the multivariate analysis. Delphian lymph node metastasis was highly predictive of further central lymph node metastasis (positive predictive value=91.7%, netative predictive value=67.9%) and moderately predictive of lateral lymph node metastasis (positive predictive value=25.0%, negative predictive value=95.5%).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2018 Year 05 Month 31 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 06 Month 22 Day

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 21 Day
Last modified on
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038589

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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