Unique ID issued by UMIN | UMIN000038572 |
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Receipt number | 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 | 2023/05/17 13:24:53 |
Multicenter prospective cohort study to investigate efficacy, quality of life and cost-effectiveness of obinutuzumab for untreated follicular lymphoma(PEACE-FL)
PEACE-FL study
Multicenter prospective cohort study to investigate efficacy, quality of life and cost-effectiveness of obinutuzumab for untreated follicular lymphoma(PEACE-FL)
PEACE-FL study
Japan |
follicular lymphoma
Hematology and clinical oncology |
Malignancy
NO
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.
Efficacy
Exploratory
Not applicable
Incremental cost- effectiveness ratio, ICER
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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
(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
Patients judged by attending physicians to be inappropriate for this study
150
1st name | Ikuyo |
Middle name | |
Last name | Tsutsumi |
National Hospital Organization Mito Medical Center
Department of Hematology
3113193
280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
029-240-7711
ikuyo.ota@gmail.com
1st name | Ikuyo |
Middle name | |
Last name | Tsutsumi |
National Hospital Organization Mito Medical Center
Department of Hematology, Clinical research center
3113193
280 Sakuranosato, Ibaraki-machi, Higashi-Ibaraki-gun, Ibaraki, JAPAN
029-240-7711
ikuyo.ota@gmail.com
Clinical Hematology Study Group of National Hospital Organization
National Hospital Organization
Other
Japan
National Health Organization Clinical Research Central Ethics Review Board
2-5-21, Higashigaoka, Meguro-ku, Tokyo
03-5712-5050
kenkyu2004@hosp.go.jp
NO
2019 | Year | 11 | Month | 13 | Day |
Unpublished
No longer recruiting
2019 | Year | 11 | Month | 07 | Day |
2019 | Year | 11 | Month | 07 | Day |
2019 | Year | 11 | Month | 18 | Day |
2025 | Year | 11 | Month | 06 | Day |
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
2019 | Year | 11 | Month | 13 | Day |
2023 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043757
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