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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019370
Receipt No. R000022395
Scientific Title Prospective observational study for advanced lung cancer with interstitial lung disease
Date of disclosure of the study information 2015/11/01
Last modified on 2020/10/21

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Basic information
Public title Prospective observational study for advanced lung cancer with interstitial lung disease
Acronym Advanced lung cancer with interstitial lung disease
Scientific Title Prospective observational study for advanced lung cancer with interstitial lung disease
Scientific Title:Acronym Advanced lung cancer with interstitial lung disease
Region
Japan

Condition
Condition Advanced lung cancer with interstitial lung disease
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prospective observation for the clinical course and prognosis of advanced lung cancer patients with interstitial lung disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety, particulary for the frequency and severity of chemotherapy-induced acute exacerbation of interstitial lung disease
Key secondary outcomes Efficacy including response rate and progression-free survival

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. Diagnosed with primary lung cancer with histopathological evidence
2. Chemotherapy-naiive
3. Advanced clinical stage without indication for curative surgery and radiotherapy
4. Preexisting interstitial lung disease on chest computed tomography at the time of lung cancer diagnosis
5. Written informed consent
Key exclusion criteria 1. Post-radiation fibrosis alone
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Takafumi
Middle name
Last name Suda
Organization Hamamatsu University School of Medicine
Division name Second division, Department of internal medicine
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
TEL +8153-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Enomoto
Organization Hamamatsu University School of Medicine
Division name Second division, Department of internal medicine
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
TEL +8153-435-2263
Homepage URL
Email enomotoy@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization none
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 Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu City 431-3192, Japan
Tel +8153-435-2680
Email rinri@hama-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 浜松医科大学付属病院、聖隷三方原病院、聖隷浜松病院、遠州病院、天竜病院、浜松労災病院、浜松日赤病院、浜松医療センター、磐田市立病院、藤枝市立総合病院、静岡市立静岡病院、静岡市立清水病院、静岡日赤病院、静岡県立総合病院、静岡済生会総合病院

Other administrative information
Date of disclosure of the study information
2015 Year 11 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 124
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
2015 Year 11 Month 01 Day
Date of IRB
2015 Year 10 Month 01 Day
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Cohort study (multiinstitutional prospective observational study)
Subjects: Patients, diagnosed with lung cancer and interstitial lung disease between November 2015 and September 2020, who fulfill our inclusion criteria
Evaluation items:
Pretreatment examination data such as laboratory tests (KL-6, SP-D, LDH, CRP), pulmonary function tests, and computed tomography; efficacy and safety of chemotherapy; prognosis

Management information
Registered date
2015 Year 10 Month 15 Day
Last modified on
2020 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022395

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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