UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056691 |
|---|---|
| Receipt number | R000064802 |
| Scientific Title | Human papillomavirus-associated lacrimal apparatus squamous cell carcinoma: a systematic review |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/12 12:27:48 |
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Basic information
Public title
Human papillomavirus-associated lacrimal apparatus squamous cell carcinoma: a systematic review
Acronym
HPV-associated lacrimal cancer: a systematic review
Scientific Title
Human papillomavirus-associated lacrimal apparatus squamous cell carcinoma: a systematic review
Scientific Title:Acronym
HPV-associated lacrimal cancer: a systematic review
Region
| Japan |
Condition
Condition
lacrimal apparatus squamous cell carcinoma
Classification by specialty
| Ophthalmology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This systematic review aimed to analyse the prevalence, clinical features, and outcomes of HPV-associated LASCC.
Basic objectives2
Others
Basic objectives -Others
epidemiology
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HPV detection rate, HPG genotypes
Key secondary outcomes
clinical features (age, sex, sites, and treatment 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
(1) HPV DNA or RNA detected by in situ hybridization (ISH) or polymerase chain reaction (PCR); (2) primary SCC arising in the LA.
Key exclusion criteria
(1) non-human studies and those in languages other than English or Japanese and (2) recurrent and/or metastatic cases.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yukinori |
| Middle name | |
| Last name | Takenaka |
Organization
The university of Osaka
Division name
Graduate school of medicine, department of otorhinolaryngology-head and neck surgery
Zip code
5650871
Address
2-2 yamadaoka, suita, Osaka
TEL
0668793951
ytakenaka@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Takenaka |
Organization
University of Osaka
Division name
Graduate school of medicine
Zip code
5650874
Address
2-2 yamadaoka, suita, Osaka
TEL
06-6879-3951
Homepage URL
ytakenaka@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
University of Osaka
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Osaka University Hospital
Address
2-15 yamadaoka, suita, osaka
Tel
06-6210-8296
rinri@ho-crc.med.osaka-u.ac.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 | 01 | Month | 14 | 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 | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A systematic search of PubMed, Scopus, and Ichushi-Web databases was conducted for studies reporting HPV-associated LASCC up to January 2025. Inclusion criteria were primary SCC in the lacrimal apparatus with HPV detection via polymerase chain reaction (PCR) or in situ hybridization (ISH). Data on patient demographics, HPV genotypes, and clinical outcomes were extracted. A meta-analysis of HPV detection rates was performed using a fixed-effects model.
Management information
Registered date
| 2025 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064802
