UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical characteristics of papillary thyroid carcinoma patients with Delphian lymph node metastasis: a single-institution study, systemic review and meta-analysis
Title of the study (Brief title)	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	Ming Qiu
Organization	Changzheng Hospital affliated Second Military Medical University
Division name	Shanghai
Address	No. 415 in Fengyang Road in Huangpu District
TEL	86-21-81885801
Email	qium127@smmu.edu.cn

Public contact
Name of contact person	Ming Qiu
Organization	Changzheng Hospital affliated Second Military Medical University
Division name	Shanghai
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

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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%).
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