UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

英語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

一般向け試験名略称/Acronym

日本語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

英語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

科学的試験名/Scientific Title

日本語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

英語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

科学的試験名略称/Scientific Title:Acronym

日本語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

英語
Wide surgical margins may be necessary to reduce the recurrence rate and mortality in patients with localized periosteal chondrosarcoma: meta-analysis of the literature

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
periosteal chondrosarcoma

英語
periosteal chondrosarcoma

疾患区分1/Classification by specialty

整形外科学/Orthopedics

疾患区分2/Classification by malignancy

悪性腫瘍/Malignancy

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
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.

英語
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.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
local recurrence rate, distant metastasis rate, and mortality

英語
local recurrence rate, distant metastasis rate, and mortality

副次アウトカム評価項目/Key secondary outcomes

日本語

英語

試験の種類/Study type

その他・メタアナリシス等/Others,meta-analysis etc

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

適用なし/Not applicable

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
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.

英語
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.

除外基準/Key exclusion criteria

日本語
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.

英語
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.

目標参加者数/Target sample size

責任研究者/Name of lead principal investigator

日本語

名	真治
ミドルネーム
姓	塚本

英語

名	Shinji
ミドルネーム
姓	Tsukamoto

所属組織/Organization

日本語
奈良県立医科大学

英語
Nara Medical University

所属部署/Division name

日本語
整形外科

英語
Department of Orthopaedic Surgery

郵便番号/Zip code

634-8521

住所/Address

日本語
奈良県橿原市四条町８４０番地

英語
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan

電話/TEL

+81-744-22-3051

Email/Email

shinji104@mail.goo.ne.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	真治
ミドルネーム
姓	塚本

英語

名	Shinji
ミドルネーム
姓	Tsukamoto

組織名/Organization

日本語
奈良県立医科大学

英語
Nara Medical University

部署名/Division name

日本語
整形外科

英語
Department of Orthopaedic Surgery

郵便番号/Zip code

634-8521

住所/Address

日本語
奈良県橿原市四条町８４０番地

英語
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan

電話/TEL

+81-744-22-3051

試験のホームページURL/Homepage URL

Email/Email

shinji104@mail.goo.ne.jp

機関名/Institute

日本語
その他

英語
Nara Medical University

機関名/Institute
（機関選択不可の場合）

日本語
奈良県立医科大学

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Nara Medical University

機関名/Organization
（機関選択不可の場合）

日本語
Nara Medical University

組織名/Division

日本語

組織の区分/Category of Funding Organization

自己調達/Self funding

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
Nara Medical University

英語
Nara Medical University

住所/Address

日本語
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan

英語
840, Shijo-cho, Kashihara-city Nara 634-8521, Japan

電話/Tel

+81-744-22-3051

Email/Email

shinji104@mail.goo.ne.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2024

年

10

月

07

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語

英語

主な結果入力日/Results date posted

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

一般募集中/Open public recruiting

プロトコル確定日/Date of protocol fixation

2024

年

10

月

07

日

倫理委員会による承認日/Date of IRB

2024

年

10

月

07

日

登録・組入れ開始（予定）日/Anticipated trial start date

2024

年

10

月

07

日

フォロー終了(予定)日/Last follow-up date

2024

年

10

月

14

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
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).

英語
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).

登録日時/Registered date

2024

年

10

月

07

日

最終更新日/Last modified on

2024

年

10

月

07

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000063740

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063740