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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036280
Receipt No. R000041322
Scientific Title Multi-institutional retrospective study for advanced lung cancer patients with end-stage kidney disease on hemodialysis (NEJ-042)
Date of disclosure of the study information 2019/04/01
Last modified on 2020/05/19

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Basic information
Public title Surveillance of chemotherapy in lung cancer patients on hemodialysis
Acronym NEJ-042 study
Scientific Title Multi-institutional retrospective study for advanced lung cancer patients with end-stage kidney disease on hemodialysis (NEJ-042)
Scientific Title:Acronym NEJ-042 study
Region
Japan

Condition
Condition advanced lung cancer patients with end-stage kidney disease on hemodialysis
Classification by specialty
Pneumology Nephrology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of chemotherapy for patients with this condition
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes frequency of severe adverse event
Key secondary outcomes overall survival
objective response rate
time to treatment failure
frequency of each adverse events
type of anti-cancer drugs

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. histologically or cytologically confirmed lung cancer
2. Ineligible for surgery and curative radiotherapy due to cancer status
3. Complicated with end-stage renal failure on hemodialysis
Key exclusion criteria Patient, or family refuses to participate in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Seike
Organization Nippon Medical School Hospital
Division name pulmonary medicine
Zip code 113-8603
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email mseike@nms.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Minegishi
Organization Nippon Medical School Hospital
Division name Department of Medical Oncology
Zip code 113-8603
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email yminegis@nms.ac.jp

Sponsor
Institute Specified Nonprofit Corporation North East Japan Study Group
Institute
Department

Funding Source
Organization Specified Nonprofit Corporation North East Japan Study Group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nippon Medical School Hospital Research ethics committee
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel 03-3822-2131
Email app-ccr@nms.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
2019 Year 04 Month 01 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
2019 Year 01 Month 21 Day
Date of IRB
2019 Year 03 Month 20 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multi-institutional retrospective study

Management information
Registered date
2019 Year 03 Month 23 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041322

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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