UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058679 |
|---|---|
| Receipt number | R000067097 |
| Scientific Title | Regional Management of Parotid Lymph Node Metastasis from Eyelid Sebaceous Carcinoma: A Systematic Review |
| Date of disclosure of the study information | 2025/08/05 |
| Last modified on | 2026/07/29 07:52:21 |
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Basic information
Public title
Regional Management of Parotid Lymph Node Metastasis from Eyelid Sebaceous Carcinoma: A Systematic Review
Acronym
Regional Management of Parotid Lymph Node Metastasis from Eyelid Sebaceous Carcinoma: A Systematic Review
Scientific Title
Regional Management of Parotid Lymph Node Metastasis from Eyelid Sebaceous Carcinoma: A Systematic Review
Scientific Title:Acronym
Regional Management of Parotid Lymph Node Metastasis from Eyelid Sebaceous Carcinoma: A Systematic Review
Region
| Japan |
Condition
Condition
Parotid Lymph Node Metastasis from Eyelid Sebaceous Carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to systematically evaluate the available evidence regarding regional management in patients with parotid lymph node metastasis from eyelid sebaceous carcinoma. The review focuses on the extent of parotidectomy, the role of postoperative radiotherapy (PORT), and the indication and extent of neck dissection. Evidence will be synthesized according to predefined clinical questions, focusing on regional recurrence, patterns of lymph node metastasis, and oncologic outcomes to clarify the optimal regional treatment strategy for this patient population.
Basic objectives2
Others
Basic objectives -Others
This study aims to evaluate, in patients with parotid lymph node metastasis from eyelid sebaceous carcinoma, (1) the extent of parotidectomy, (2) the role of postoperative radiotherapy (PORT), and (3) the indication and extent of neck dissection according to predefined clinical questions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regional recurrence after treatment for parotid lymph node metastasis (parotid and/or cervical regional recurrence). The site of recurrence (parotid region, cervical region, in-field or out-of-field recurrence) and the time to regional recurrence will be recorded.
Key secondary outcomes
(1) Occult cervical lymph node metastasis; (2) Distribution of metastatic cervical lymph node levels; (3) Disease-free survival (DFS), overall survival (OS), and disease-specific survival (DSS); (4) Disease status at the last follow-up (no evidence of disease, alive with disease, and dead of disease); (5) Treatment-related complications; and (6) Duration of follow-up.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PEligible studies include patients with histologically confirmed parotid lymph node metastasis from eyelid sebaceous carcinoma. Patients with isolated parotid lymph node metastasis or combined parotid and cervical lymph node metastases are eligible. Studies must report details of parotid surgery, neck dissection, or postoperative radiotherapy (PORT) and provide data on regional recurrence, lymph node distribution, or oncologic outcomes. For mixed cohorts, only studies in which patients with parotid lymph node metastasis can be identified separately will be included. No restrictions will be applied regarding publication year or language.
Key exclusion criteria
The following will be excluded: (1) patients with cervical lymph node metastasis without parotid lymph node metastasis; (2) prophylactic parotidectomy cases without pathological parotid lymph node metastasis; (3) direct invasion of the parotid gland without lymph node metastasis; (4) studies in which patients with parotid lymph node metastasis cannot be identified separately; (5) single case reports, reviews, conference abstracts, editorials, letters, or other publications without original patient data; and (6) studies evaluating only sentinel lymph node biopsy, systemic therapy alone, or primary tumor treatment alone. When duplicate cohorts are identified, only the most informative report will be included.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Takahaashi |
| Middle name | |
| Last name | Takeshi |
Organization
Faculty of Medicine, Niigata University
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
951-8510
Address
Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine, Niigata University, 1-754 Asahimachidori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2305
tt_niigata@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Takahashi |
Organization
Faculty of Medicine, Niigata University
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
951-8510
Address
Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine, Niigata University, 1-754 A
TEL
025-227-2305
Homepage URL
tt_niigata@yahoo.co.jp
Sponsor or person
Institute
Faculty of Medicine, Niigata University, Niigata, Japan
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Niigata University
Address
Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine, Niigata University, 1-754 Asahimachidori, Chuo-ku, Niigata 951-8510, Japan
Tel
025-227-2305
tt_niigata@yahoo.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 05 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted in accordance with PRISMA 2020 guidelines as a systematic review and meta-analysis. A comprehensive search will be conducted in PubMed, Web of Science, and Embase for English-language articles published since 2000 that report on the treatment and outcomes of cervical lymph node or parotid gland metastases from eyelid sebaceous carcinoma.
Data Extraction
The following data will be extracted:
Patient demographics and tumor characteristics
Site of metastasis (cervical nodes, parotid gland)
Extent of parotidectomy (partial vs total)
Neck dissection (prophylactic vs therapeutic vs none)
Use of postoperative radiotherapy
Time from primary tumor treatment to metastasis (short vs long)
Number of metastatic lesions (solitary vs multiple)
Quantitative Analysis
Meta-analysis will compare the following binary variables with respect to local recurrence rate, overall survival (OS), and disease-free survival (DFS), presenting relative risks (RR) or hazard ratios (HR):
Solitary vs multiple metastases
Short vs long interval from primary treatment to metastasis
Partial vs total parotidectomy
With vs without postoperative radiotherapy
With vs without prophylactic neck dissection
Heterogeneity will be assessed using the I2 statistic. Random-effects models will be applied when appropriate. Publication bias will be evaluated using funnel plots and Eggers test. Where meta-analysis is not feasible, narrative synthesis will be provided.
Management information
Registered date
| 2025 | Year | 08 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067097
