UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055767 |
|---|---|
| Receipt number | R000063740 |
| Scientific Title | Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/10/07 19:01:13 |
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Basic information
Public title
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature
Acronym
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature
Scientific Title
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature
Scientific Title:Acronym
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature
Region
| Japan |
Condition
Condition
periosteal chondrosarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to perform a systematic review of the literature to determine the relationship between surgical margins and local recurrence rate, distant metastasis rate, and mortality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
local recurrence rate, distant metastasis rate, and mortality
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
Only studies that reported clinical outcome after R0 or R1 resection of localized PCS were included; patients with distant metastasis at diagnosis were excluded. Patients without specified local recurrence, distant metastasis, and death of tumor, and follow up period, were also excluded. Studies without a control group were excluded. We included literature on humans and excluded studies on animals. Only English-language literature was included, with no restriction on the year of publication.
Key exclusion criteria
Only studies that reported clinical outcome after R0 or R1 resection of localized PCS were included; patients with distant metastasis at diagnosis were excluded. Patients without specified local recurrence, distant metastasis, and death of tumor, and follow up period, were also excluded. Studies without a control group were excluded. We included literature on humans and excluded studies on animals. Only English-language literature was included, with no restriction on the year of publication.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Tsukamoto |
Organization
Nara Medical University
Division name
Department of Orthopaedic Surgery
Zip code
634-8521
Address
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
TEL
+81-744-22-3051
shinji104@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Tsukamoto |
Organization
Nara Medical University
Division name
Department of Orthopaedic Surgery
Zip code
634-8521
Address
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
TEL
+81-744-22-3051
Homepage URL
shinji104@mail.goo.ne.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Nara Medical University
Address
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan
Tel
+81-744-22-3051
shinji104@mail.goo.ne.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
| 2024 | Year | 10 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Meta-analysis of data
In localized PCS patients, the local recurrence rate was lower in the R0 resection group than in the R1 resection group: 2.5% (3/118 patients) in the R0 resection group and 33.3% (11/33 patients) in the R1 resection group (Table 2). The overall pooled odds ratio was 10.4 (95% confidence interval, 3.22 to 33.67; p < 0.001), and the heterogeneity I2 was 0% (Fig. 4a). In localized PCS patients, the distant metastasis rate was lower in the R0 resection group than in the R1 resection group: 5.9% (7/118 patients) in the R0 resection group and 27.3% (9/33 patients) in the R1 resection group (Table 2). The overall pooled odds ratio was 4.55 (95% confidence interval, 1.44 to 14.39; p = 0.010), and the heterogeneity I2 was 0% (Fig. 4b). In localized PCS patients, the mortality rate was lower in the R0 resection group than in the R1 resection group: 4.2% (5/118 patients) in the R0 resection group and 18.2% (6/33 patients) in the R1 resection group (Table 2). The overall pooled odds ratio was 3.42 (95% confidence interval, 1.06 to 11.09; p = 0.040), and the heterogeneity I2 was 0% (Fig. 4c).
Management information
Registered date
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063740
