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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038826
Receipt No. R000044274
Scientific Title Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review
Date of disclosure of the study information 2019/12/09
Last modified on 2019/12/09

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Basic information
Public title Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review
Acronym Lung metastases from GCTB: A systematic review
Scientific Title Which is the better treatment for lung metastases from giant cell tumor of bone, metastasectomy or non-metastasectomy? A systematic review
Scientific Title:Acronym Lung metastases from GCTB: A systematic review
Region
Japan Europe

Condition
Condition Lung metastases from giant cell tumor of bone
Classification by specialty
Chest surgery Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We are going to perform a systematic review of comparative studies to determine whether metastasectomy can decrease the tumor-related death in patients with operable lung metastasis from GCTB compared with non-metastasectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes We counted only tumor-related death as the outcome, and excluded the death unrelated to disease and the death related to chemotherapy.
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 All comparative reports examining tumor-related death in patients who had giant cell tumors of bone and operable lung metastases and were treated with metastasectomy and non-metastasectomy, were included. Metastasectomy group included patients treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy.Non-metastasectomy group included patients treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy.We included human studies and articles with clearly-described death following treatment for lung metastases. We counted only tumor-related death, and excluded the death unrelated to disease and the death related to chemotherapy.
Key exclusion criteria The patients who had inoperable lung metastases and were treated with observation, chemotherapy, or radiotherapy, were excluded.We excluded studies without a comparison group, those without a report of tumor-related death, isolated case reports or case series including fewer than five patients and non-English and non-Japanese language abstracts. We did not place any restrictions on the date of publication.
Target sample size 100

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 0744-22-3051
Email 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 0744-22-3051
Homepage URL
Email shinji104@mail.goo.ne.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical 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 Nara Medical University
Address 840, Shijo-cho, Kashihara-city, Nara 634-8521, Japan
Tel 0744-22-3051
Email 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
2019 Year 12 Month 09 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
2019 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 09 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Two authors (ST and AK) independently selected the studies and extracted the data. In cases of disagreement, a consensus was either achieved between them, or by consulting a third author. A data collection sheet was used to collate the following data: (1) basic data: authors, year of publication, name of publishing journal, type of study, and total number of patients, and the length of follow-up; (2) number of patients in the metastasectomy and the non-metastasectomy groups, and proportions of patients with tumor-related death in the metastasectomy and the non-metastasectomy groups; the each total number and tumor-related death number of patients who were treated with metastasectomy alone, metastasectomy and chemotherapy, metastasectomy and radiotherapy, and metastasectomy, chemotherapy and radiotherapy in the metastasectomy group; the each total number and tumor-related death number of patients who were treated with observation alone, chemotherapy alone, and chemotherapy and radiotherapy in the non-metastasectomy group; (3) characteristics of the metastasectomy and the non-metastasectomy groups such as interval to lung metastases, number and extent of the lung lesions (solitary or multiple lesion, unilateral or bilateral lesion), and tendency to increase of the lung lesion (progression, stable or regression); (4) resection status (complete or incomplete resection) in the metastasectomy group; the chemotherapy regimen.

Management information
Registered date
2019 Year 12 Month 09 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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