UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015121
Receipt number 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 14:43:05

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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 or person

Institute

The Cancer Institute Hospital Of JFCR

Institute

Department

Personal name



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

Value
https://center6.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