UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052577 |
|---|---|
| Receipt number | R000059923 |
| Scientific Title | A multi-institutional observational study of newly-diagnosed pulmonary mucosa-associated lymphoid tissue lymphoma in Japan (PALM-T study) |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2024/04/23 16:04:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multi-institutional observational study of newly-diagnosed pulmonary mucosa-associated lymphoid tissue lymphoma in Japan (PALM-T study)
Acronym
A multi-institutional observational study of newly-diagnosed pulmonary mucosa-associated lymphoid tissue lymphoma in Japan (PALM-T study)
Scientific Title
A multi-institutional observational study of newly-diagnosed pulmonary mucosa-associated lymphoid tissue lymphoma in Japan (PALM-T study)
Scientific Title:Acronym
A multi-institutional observational study of newly-diagnosed pulmonary mucosa-associated lymphoid tissue lymphoma in Japan (PALM-T study)
Region
| Japan |
Condition
Condition
pulmonary mucosa-associated lymphoid tissue lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate clinical features, treatment choice, toxicity, and survival in pulmonary MALT lymphoma patients diagnosed between 2013 and 2022 at participating institutes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of patients with newly-diagnosed pulmonary MALT lymphoma diagnosed between 2013 and 2022 at participating institutes
Key secondary outcomes
Clinical features, treatment choice, toxicity, and risk factors affecting survival in pulmonary MALT lymphoma patients diagnosed between 2013 and 2022 at participating institutes
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
Patients who meet all of the following criteria are eligible.
1. Patients who were histologically diagnosed with MALT lymphoma between January 1, 2013 and December 31, 2022
2. Patients who have involvement of the lung (lung biopsy is not mandatory)
Key exclusion criteria
Patients with one or more of the following are excluded.
1. Patients who were diagnosed as not pulmonary MALT lymphoma based on diagnosis-related information
2. Patients who refused to consent to opt-out
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematological Malignancies
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
myamaguchi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Yamaguchi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Hematological Malignancies
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
Homepage URL
myamaguchi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research and Development Fund
The Japanese Society of Hematology Research Grant
Mie University Graduate School of Medicine
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
Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-232-1111
kk-sien@med.mie-u.ac.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
愛育病院（北海道）
秋田大学医学部附属病院（秋田県）
国立病院機構渋川医療センター（群馬県）
埼玉医科大学国際医療センター（埼玉県）
東京慈恵会医科大学附属病院（東京都）
公益財団法人がん研究会有明病院（東京都）
神奈川県立がんセンター（神奈川県）
聖マリアンナ医科大学（神奈川県）
信州大学医学部附属病院（長野県）
金沢大学附属病院（石川県）
金沢医科大学（石川県）
福井大学医学部附属病院（福井県）
岐阜大学医学部附属病院（岐阜県）
藤田医科大学病院（愛知県）
名古屋市立大学病院（愛知県）
藤田医科大学岡崎医療センター（愛知県）
日本赤十字社愛知医療センター名古屋第二病院（愛知県）
豊田厚生病院（愛知県）
三重大学大学院医学系研究科（三重県）
京都大学医学部附属病院（京都府）
京都第一赤十字病院（京都府）
京都第二赤十字病院（京都府）
兵庫県立がんセンター（兵庫県）
神戸市立医療センター中央市民病院（兵庫県）
島根大学医学部附属病院（島根県）
国立病院機構岡山医療センター（岡山県）
岡山赤十字病院（岡山県）
独立行政法人国立病院機構九州がんセンター（福岡県）
長崎大学病院（長崎県）
熊本大学病院（熊本県）
鹿児島大学大学院医歯学総合研究科（鹿児島県）
長野県立信州医療センター（長野県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 26 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059923
