UMIN-CTR Clinical Trial

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
Email	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
Email	nobak39@yahoo.co.jp

Sponsor
Institute	Teikyo University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055724