UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033835 |
|---|---|
| Receipt number | 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 13:37:33 |
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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
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
qium127@smmu.edu.cn
Sponsor or person
Institute
Changzheng Hospital
General surgery department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038589
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