UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055676 |
|---|---|
| Receipt number | R000063620 |
| Scientific Title | Retrospective study of drug therapy in malignant pleural mesothelioma(NEJ065) |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/10/01 10:40:52 |
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Basic information
Public title
Retrospective study of drug therapy in malignant pleural mesothelioma(NEJ065)
Acronym
NEJ065
Scientific Title
Retrospective study of drug therapy in malignant pleural mesothelioma(NEJ065)
Scientific Title:Acronym
NEJ065
Region
| Japan |
Condition
Condition
malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using real clinical data in patients with malignant pleural mesothelioma treated with pharmacotherapy, we will examine the evolution of the therapeutic paradigm that led to the use of immune checkpoint inhibitors in pharmacotherapy, and their efficacy and safety. In addition, the role of the treatment sequence for malignant pleural mesothelioma will be investigated by also examining the actual drug therapy prior to the use of immune checkpoint inhibitors.Translated with DeepL.com (free version)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gender,age,PS/height,and weight at start of drug therapy regimen,Any history of asbestos exposure (if any, specific occupation)
Key secondary outcomes
Histological types (epithelial,sarcomatoid,biphasic,other),UICC TNM classification (III,I,Vpostoperative recurrence,recurrence after chemoradiotherapy),presence of pleural effusion,Blood test findings (neutrophil count,lymphocyte count,platelet count,serum albumin,CRP,LDH)
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
1.Pathological (histological or cytological) diagnosis of malignant pleural mesothelioma.
2.Patients whose stage of disease at diagnosis makes radical surgery or radical (chemo-)radiotherapy difficult or who have recurred after radical surgery or radical (chemo-)radiotherapy and who have been treated with cancer chemotherapy.
3.Initial drug therapy was initiated within the above time period.
4.Patients who have been fully informed of the enrollment in this study,and who have given written consent of their own free will based on sufficient understanding.
Key exclusion criteria
1.Patients enrolled in prospective clinical trials (intervention studies)
2.Patients deemed inappropriate by the physician in charge for reasons such as inability to collect the information necessary to complete the Case Report Form (CRF).
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kaira |
| Middle name | |
| Last name | Kyoichi |
Organization
Saitama Medical University International Medical Center
Division name
Respiratory Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka City, Saitama
TEL
042-984-4111
kkaira@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Imai |
| Middle name | |
| Last name | Hisao |
Organization
Saitama Medical University International Medical Center
Division name
Respiratory Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka City, Saitama
TEL
042-984-4111
Homepage URL
hisao725@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
nil
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center Clinical Research Ethics Review Committee
Address
1397-1 Yamane, Hidaka City, Saitama
Tel
042-984-4523
imc_irb@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Patients who meet all of the following enrollment criteria between January 1, 2007 and December 31, 2022 will be eligible. Selected patients are consecutive cases that meet all criteria
Patients whose stage of disease at diagnosis makes radical surgery or radical (chemo-)radiotherapy difficult or who have recurred after radical surgery or radical (chemo-)radiotherapy and who have received cancer chemotherapy.
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063620
