UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029534 |
|---|---|
| Receipt number | R000033733 |
| Scientific Title | Study of patient risk factors for febrile neutropenia in NHL receiving (R)CHOP regimen 2 |
| Date of disclosure of the study information | 2017/10/13 |
| Last modified on | 2020/04/22 21:04:18 |
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Basic information
Public title
Study of patient risk factors for febrile neutropenia in NHL receiving (R)CHOP regimen 2
Acronym
STOP FN in NHL 2
Scientific Title
Study of patient risk factors for febrile neutropenia in NHL receiving (R)CHOP regimen 2
Scientific Title:Acronym
STOP FN in NHL 2
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.
Examine the incidence of hospitalization due to FN and the use of antibiotics.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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 NHL
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Hatake |
Organization
The Cancer Institute Hospital Of JFCR
Division name
Hematological Oncology Department
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo
TEL
03-3520-0111
khatake@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nukada |
Organization
Kyowa Kirin
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
ma.oncology@kyowa-kirin.co.jp
Sponsor or person
Institute
The Cancer Institute Hospital Of JFCR
Institute
Department
Personal name
Funding Source
Organization
Kyowa 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
Cancer Institute Hospital Japanese Foundation For Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, JAPAN
Tel
03-3520-0111
med.shinsa@jfcr.or.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
| 2017 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
https://rd.springer.com/article/10.1007/s00520-019-04802-4
Number of participants that the trial has enrolled
239
Results
Refer to the article
Results date posted
| 2020 | Year | 04 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Non Hodgkin's Lymphoma
Participant flow
A total of 239 patients were evaluated and the most common pathological diagnosis was diffuse large B cell lymphoma.
Adverse events
None
Outcome measures
Incidence of FN during the 1st cycle of chemotherapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 26 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 12 | Day |
Other
Other related information
Retrospective observational study.
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2020 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033733
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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