UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058679 |
|---|---|
| Receipt number | R000067097 |
| Scientific Title | Management and Prognosis of Cervical Lymph Node and Parotid Gland Metastases from Sebaceous Carcinoma of the Eyelid: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2025/08/05 |
| Last modified on | 2025/08/02 17:59:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Management and Prognosis of Cervical Lymph Node and Parotid Gland Metastases from Sebaceous Carcinoma of the Eyelid: A Systematic Review and Meta-analysis
Acronym
Management and Prognosis of Cervical Lymph Node and Parotid Gland Metastases from Sebaceous Carcinoma of the Eyelid: A Systematic Review and Meta-analysis
Scientific Title
Management and Prognosis of Cervical Lymph Node and Parotid Gland Metastases from Sebaceous Carcinoma of the Eyelid: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Management and Prognosis of Cervical Lymph Node and Parotid Gland Metastases from Sebaceous Carcinoma of the Eyelid: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
Cervical Lymph Node and Parotid Gland Metastases from Sebaceous Carcinoma of the Eyelid
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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 Ichushi for English-and Japanese language articles published since 2000 that report on the treatment and outcomes of cervical lymph node or parotid gland metastases from eyelid sebaceous carcinoma.
Basic objectives2
Others
Basic objectives -Others
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)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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 Egger's test. Where meta-analysis is not feasible, narrative synthesis will be provided.
Key secondary outcomes
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
Population
Patients with sebaceous carcinoma of the eyelid who developed cervical lymph node and/or parotid gland metastases.
Intervention / Exposure
Surgical management including parotidectomy, neck dissection, and/or postoperative radiotherapy.
Outcomes
Studies reporting at least one of the following:
Local recurrence rate
Overall survival (OS)
Disease-free survival (DFS)
Study Design
Case reports, case series, retrospective cohort studies, or other observational studies.
Language
Articles published in English and Japanese
Publication Year
Studies published from 2000 onward.
Key exclusion criteria
Primary site other than eyelid
Studies on extraocular sebaceous carcinoma (e.g., trunk, scalp).
No relevant metastasis
Studies that do not describe cervical lymph node or parotid gland involvement.
Lack of treatment or outcome data
Articles that do not report surgical details or oncologic outcomes.
Non-human studies, reviews, conference abstracts, editorials, or letters without original patient data.
Duplicate publications
When multiple reports describe the same patient cohort, only the most comprehensive 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
| 2025 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067097
