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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038572
Receipt No. R000043757
Scientific Title Multicenter prospective cohort study to investigate efficacy, quality of life and cost-effectiveness of obinutuzumab for untreated follicular lymphoma(PEACE-FL)
Date of disclosure of the study information 2019/11/13
Last modified on 2019/11/13

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Basic information
Public title Multicenter prospective cohort study to investigate efficacy, quality of life and cost-effectiveness of obinutuzumab for untreated follicular lymphoma(PEACE-FL)
Acronym PEACE-FL study
Scientific Title Multicenter prospective cohort study to investigate efficacy, quality of life and cost-effectiveness of obinutuzumab for untreated follicular lymphoma(PEACE-FL)
Scientific Title:Acronym PEACE-FL study
Region
Japan

Condition
Condition follicular lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinical outcome, quality of life, cost and cost-effectiveness of obinutuzumab in untreated follicular lymphoma, and also to explore prognostic factors in a new drug era for untreated follicular lymphoma using multicenter prospective cohort data.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incremental cost- effectiveness ratio, ICER
Key secondary outcomes Overall survival, OS
Progression free survival, PFS
POD24 (Progression of disease within 24 months)
Overall response rate, ORR
Complete response rate, CRR
Quality of life, QOL
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 (1)Adult patients over 20 years old at the time of enrollment
(2)Patients who have been histopathological diagnosed with follicular lymphoma according to WHO classification revision 4th edition (2017) within 6 months of enrollment
(3)Patients diagnosed as follicuar lymphoma grade 1, grade 2 or grade 3a by histopathology
Key exclusion criteria Patients judged by attending physicians to be inappropriate for this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Ikuyo
Middle name
Last name Tsutsumi
Organization National Hospital Organization Mito Medical Center
Division name Department of Hematology
Zip code 3113193
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 Ikuyo
Middle name
Last name Tsutsumi
Organization National Hospital Organization Mito Medical Center
Division name Department of Hematology, Clinical research center
Zip code 3113193
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 National Health Organization Clinical Research Central Ethics Review Board
Address 2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel 03-5712-5050
Email kenkyu2004@hosp.go.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
2019 Year 11 Month 13 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
2019 Year 11 Month 07 Day
Date of IRB
2019 Year 11 Month 07 Day
Anticipated trial start date
2019 Year 11 Month 18 Day
Last follow-up date
2025 Year 11 Month 06 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: 3 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) Physical findings
(2) Characteristics of patients
(3) Laboratory test results
(4) Image inspection date and findings
(5) QOL: EQ-5D-5L and EORTC QLQ-C30
(6) Contents of treatment and date of treatment implementation
(7) Determination of therapeutic effect
(8) Confirmation date of progression / relapse / death
(9) Last survival confirmation date
(10) Clinical outcome

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043757

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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