UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052042 |
|---|---|
| Receipt number | R000059398 |
| Scientific Title | Associations between clinicopathological factors and p21 expression in oral squamous cell carcinoma: A meta-analysis |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/08/29 16:35:16 |
* 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
Significance of p21 expression in oral squamous cell carcinoma
Acronym
p21 expression in oral squamous cell carcinoma
Scientific Title
Associations between clinicopathological factors and p21 expression in oral squamous cell carcinoma: A meta-analysis
Scientific Title:Acronym
p21 expression in oral squamous cell carcinoma: A meta-analysis
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
oral squamous cell carcinoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In Japan, oral cancer accounts for almost 1% of all cancers and an increasing number of deaths. Oral squamous cell carcinoma (OSCC) is the most common histological type of oral cancer, and surgical resection is the common treatment for oral cancer. Patients with advanced cancer have a significantly worse quality of life than those with early cancer. Therefore, searching for immunostaining markers associated with clinicopathological factors in oral cancer is considered to be significant because preoperative searches can be used to guide treatment strategies.
Although there are several reports on p21 expression in oral squamous cell carcinoma, its significance is unclear. We will performe a meta-analysis to evaluate the associations between clinicopathological factors and the p21 expression in OSCC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will performe a meta-analysis to evaluate the associations between clinicopathological factors and the p21 expression in OSCC.
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
PubMed and Web of Science were searched to identify papers. We also searched the reference lists of the included papers. The following search keywords were used: oral squamous cell carcinoma, p21, and clinicopathological.
Key exclusion criteria
We excluded studies published in languages other than Japanese or English as well as those that used cultured cells or animal experiments, case reports, review articles, and papers lacking data on relationships between clinicopathological factors and p21 expression.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Department of Medical Laboratory Sciences, School of Allied Health Sciences Kitasato University
Division name
Pathology
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8300
hitakaha@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Department of Medical Laboratory Sciences, School of Allied Health Sciences Kitasato University
Division name
Pathology
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8300
Homepage URL
hitakaha@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Medical Laboratory Sciences, School of Allied Health Sciences Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Laboratory Sciences, School of Allied Health Sciences Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Medical Laboratory Sciences, School of Allied Health Sciences Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8300
hitakaha@med.kitasato-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
| 2023 | Year | 10 | Month | 01 | 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
| 2023 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search strategy
PubMed and Web of Science will be searched to identify papers. We will also search the reference lists of the included papers. The following search keywords will be used: oral squamous cell carcinoma, p21, and clinicopathological.
Eligibility criteria
We will select studies that examined the relationship between clinicopathological factors evaluated in surgical specimens of oral squamous cell carcinoma and p21 expression by immunostaining. We will exclude studies published in languages other than Japanese or English as well as those that used cultured cells or animal experiments, case reports, review articles and papers lacking data on relationships between clinicopathological factors and p21 expression.
Statistical analysis
Statistical analysis will be performed using Review Manager 5.4 (Cochrane Collaboration, Oxford, UK) to combine data and the effect estimate. A random effects model will be used because of the presumed differences in the populations among the included studies. The effect estimates will be presented with the 95% confidence interval (CI). The intervention effects will be measured using odds ratios. The heterogeneity among studies will be calculated using the I2 values. Publication bias will be assessed using funnel plots for the primary endpoint.
Management information
Registered date
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059398
