UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048906 |
|---|---|
| Receipt number | R000055724 |
| Scientific Title | Predictive accuracy of the MASCC and CISNE scores for selecting febrile neutropenia patients as candidates for outpatient treatment: A systematic review and meta-analysis. |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2022/09/10 19:35:26 |
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Basic information
Public title
Predictive accuracy of the MASCC and CISNE scores for selecting febrile neutropenia patients as candidates for outpatient treatment: A systematic review and meta-analysis.
Acronym
A systematic review and meta-analysis on the predictive accuracy of the MASCC and CISNE scores.
Scientific Title
Predictive accuracy of the MASCC and CISNE scores for selecting febrile neutropenia patients as candidates for outpatient treatment: A systematic review and meta-analysis.
Scientific Title:Acronym
A systematic review and meta-analysis on the predictive accuracy of the MASCC and CISNE scores.
Region
| Japan |
Condition
Condition
febrile neutropenia
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A systematic review and meta-analysis will be done to determine the accuracy of the MASCC and CISNE scores in assessing the risk of febrile neutropenic patients and the appropriateness of selecting patients for outpatient treatment based on these scores.
Basic objectives2
Others
Basic objectives -Others
Summary sensitivity and specificity of the MASCC and CISNE scores on serious complications and death, the morbidity of serious complications and mortality in pooled data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Summary sensitivity and specificity of the MASCC and CISNE scores on serious complications and death
Key secondary outcomes
The morbidity of serious complications and mortality in pooled data
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The report which fulfills the following characteristics is enrolled.
The enrolled patients were older than 15 years old.
Febrile neutropenic patients were consecutively enrolled in the study.
The enrolled patients were stratified by the MASCC or CISNE score, and the number of patients in each risk group is described or calculated from the figures in the article.
The outcome is designed as a serious complications according to Klastersky et al. or its equivalent, or death.
The number of patients in each risk group is described, or it is possible to calculate the number from the figures in the article.
Key exclusion criteria
Exclude papers that
Studies involving children under 15 years of age.
Studies that excluded severe cases of febrile neutropenia.
Studies with a MASCC score cutoff other than 21.
Studies with a CISNE score cutoff other than 0 or 3.
Studies in which the outcome differed from the serious complication by Klastersky et al. and therefore not appropriate for comparison with other studies.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobu |
| Middle name | |
| Last name | Akiyama |
Organization
Teikyo University
Division name
School of Medicine
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ward, Tokyo
TEL
03-3964-1211
nobak39@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobu |
| Middle name | |
| Last name | Akiyama |
Organization
Teikyo University
Division name
School of Medicine
Zip code
173-8605
Address
2-11-1, Kaga, Itabashi-ward, Tokyo
TEL
03-3964-1211
Homepage URL
nobak39@yahoo.co.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo 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
not applicable
Address
not applicable
Tel
not applicable
not applicable
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
| 2022 | Year | 09 | Month | 10 | 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
| 2022 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2022 | Year | 09 | Month | 10 | Day |
Last modified on
| 2022 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055724
