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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026684
Receipt No. R000030023
Scientific Title A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma.
Date of disclosure of the study information 2017/03/25
Last modified on 2019/03/25

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Basic information
Public title A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma.
Acronym NHOH-CUA-DLBCL
Scientific Title A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma.
Scientific Title:Acronym NHOH-CUA-DLBCL
Region
Japan

Condition
Condition Untreated limited-stage DLBCL
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the cost-effectiveness of a long course of R-CHOP therapy and radiation therapy after a short course of R-CHOP therapy respectively in Japan in treatment naive adults with untreated limited-stage DLBCL. Also to clarify the actual condition of treatment outcome, QOL and treatment-related cost, and to search for background factors of patients related to doctor's treatment selection in the limited-stage DLBCL.
Basic objectives2 Others
Basic objectives -Others Net monetary benefit,Incremental cost- effectiveness ratio,
Cost
Quality of life
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the cost-effectiveness in clinical practice of untreated limited-stage DLBCL.
Net monetary benefit (NMB)

Key secondary outcomes To clarify the actual condition of treatment outcome, QOL, treatment-related cost and the cost-effectiveness in the limited-stage DLBCL.
Incremental cost-effectiveness ratio (ICER),Overall survival (OS),Progression Free Survival (PFS),
Overall response rate (ORR) of the best overall response in the first treatment period,
Complete response rate (CRR) of the best overall response in the first treatment period,Quality of Life (QOL),Treatment-related cost.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients fulfilling all of the following criteria:
1) Adult patients of 20 years or older at time of registration.
2) Patients who are diagnosed with DLBCL in histopathological diagnosis according to WHO Classification 4th Edition (2008).
3) Treatment naive patients with first episode of DLBCL.
4) Patients in limited-stage of I/IE or II/IIE according to Ann Arbor staging (Cotswolds modification) and without bulky diseases.
5) Patients who are scheduled to undergo R-CHOP therapy.
6) Patients who provided written consents for this study.
Key exclusion criteria 1) Patients with central nervous/meningeal infiltration.
2) Patients with mental illness or impaired cognitive function at time of registration and with difficulty in writing and reading by themselves.
3) Patients with impaired vision at time of registration and with difficulty in writing and reading by themselves.
4) Patients for whom the attending doctor decided not suitable for participation in this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuyo O. Tsutsumi
Organization National Hospital Organization Mito Medical Center
Division name Department of Hematology, Clinical research center
Zip code
Address 280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL 029-240-7711
Email ikuyo.ota@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ikuyo O. Tsutsumi
Organization National Hospital Organization Mito Medical Center
Division name Department of Hematology , Clinical research center
Zip code
Address 280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
TEL 029-240-7711
Homepage URL
Email ikuyo.ota@gmail.com

Sponsor
Institute Clinical Hematology Study Group of National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2017 Year 03 Month 25 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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 09 Day
Date of IRB
2017 Year 03 Month 06 Day
Anticipated trial start date
2017 Year 03 Month 27 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: a prospective cohort study.
Recruitment of subject: all patients who visited the study site during the registration period and fulfill the inclusion criteria.
Registration period: 2 years after the approval of National Hospital Organization Central Research Ethics Committee (hereinafter referred to as the "Central Research Ethics Committee").
Items to be measured:
(1) Characteristics of patients
(2) International prognostic index (IPI)
(3) Stage (according to Ann Arbor classification)
(4) Baseline of lesion site/range
(5) QOL: EQ-5D-5L and EORTC QLQ-C30
(6) Contents of treatment and date of treatment implementation
(7) Determination of therapeutic effect
(8) Adverse events: Grade 3 or more according to CTCAE v4.0-JCOG

Management information
Registered date
2017 Year 03 Month 24 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030023

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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