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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015121
Receipt No. R000017588
Scientific Title Study Of Patient risk factors for Febrile Neutropenia in NHL patients receiving (R)CHOP regimen
Date of disclosure of the study information 2014/09/12
Last modified on 2018/04/17

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Basic information
Public title Study Of Patient risk factors for Febrile Neutropenia in NHL patients receiving (R)CHOP regimen
Acronym STOP FN in NHL
Scientific Title Study Of Patient risk factors for Febrile Neutropenia in NHL patients receiving (R)CHOP regimen
Scientific Title:Acronym STOP FN in NHL
Region
Japan

Condition
Condition Non Hodgkin's Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determine the incidence of FN in NHL patients receiving (R)CHOP regimen. Explore the risk factors of FN in (R)CHOP regimen treated NHL patients by analyzing the relationship between FN and patient background factors.
Basic objectives2 Others
Basic objectives -Others Incidence of FN in HNL patients
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of FN during the 1st cycle of chemotherapy in NHL patients
Key secondary outcomes

Base
Study type Observational

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 NHL patients received (R)CHOP regimen
Key exclusion criteria HIV related HNL
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyohiko Hatake
Organization The Cancer Institute Hospital Of JFCR
Division name Hematological Oncology Department
Zip code
Address 3-8-31, Ariake, Koto, Tokyo
TEL 03-3520-0111
Email khatake@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name tomoyuki nukada
Organization Kyowa Hakko Kirin Co., Ltd.
Division name Medical Affairs
Zip code
Address 1-9-2, Ohtemachi, Chiyoda-ku, Tokyo, Japan
TEL 03-5205-7200
Homepage URL
Email ma.oncology@kyowa-kirin.co.jp

Sponsor
Institute The Cancer Institute Hospital Of JFCR
Institute
Department

Funding Source
Organization Kyowa Hakko Kirin Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://rd.springer.com/article/10.1007/s00520-017-3747-z
Number of participants that the trial has enrolled
Results Refer to the article
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 Completed
Date of protocol fixation
2014 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective research of FN incidence in NHL patients

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017588

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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