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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016838
Receipt No. R000019547
Scientific Title Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Extensive-Stage Small-Cell Lung Cancer
Date of disclosure of the study information 2015/03/20
Last modified on 2016/09/21

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Basic information
Public title Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Extensive-Stage Small-Cell Lung Cancer
Acronym Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Extensive-Stage Small-Cell Lung Cancer
Scientific Title Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Extensive-Stage Small-Cell Lung Cancer
Scientific Title:Acronym Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Extensive-Stage Small-Cell Lung Cancer
Region
Japan

Condition
Condition Extensive-Stage Small-Cell Lung Cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the prognostic impact of serum autoantibody (anti-CTLA-4 antibody, anti-PD-1 antibody, anti-BTLA antibody and anti-RPL29 antibody) in patients with extensive-stage small-cell lung cancer
Basic objectives2 Others
Basic objectives -Others To evaluate the association between serum anti-RPL29 antibody levels and overall survival
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The association between serum anti-RPL29 antibody levels and overall survival
Key secondary outcomes 1, The association between serum anti-RPL29 antibody levels and progression-free survival in first-line chemotherapy
2, The association of serum anti-CTLA-4 antibody levels with overall survival or progression-free survival in first-line chemotherapy
3, The association of serum anti-PD-1 antibody levels with overall survival or progression-free survival in first-line chemotherapy
4, The association of serum anti-BTLA antibody levels with overall survival or progression-free survival in first-line chemotherapy

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Written voluntary informed consent
2.Patients aged >= 20 years
3.Pathologically-confirmed small-cell lung cancer
4.Extensive-stage disease
5.Standard platinum-containing chemotherapy is scheduled as first-line chemotherapy
6.Performance Status of 0 or 1 (Eastern Cooperative Oncology Group)
7.Adequate organ function
Key exclusion criteria 1.Concomitant other malignancy
2.Life expectancy <= 3 months
3.Use of steroid hormone, immunosuppressant, or biologic drug within 4 weeks at the time of enrollment
4.Severe active infection or poorly controlled disease ( e.g. hypertension, diabetes mellitus, cardiac disorder, gastro-intestinal bleeding, and so on)
5.Pregnant, possibly pregnant or lactating woman
6.Requiring radiation therapy to brain, mediastinum, or lung
7.Concomitant obvious interstitial lung disease on chest computed tomography
8.Poorly controlled malignant effusion requiring drainage
9.Otherwise determined by the investigator or the attending physician to be unsuitable as a subject in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshige Yoshioka
Organization Kurashiki Central Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 086-422-0210
Email hirotin@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ikeo
Organization Kyoto University Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL 086-422-0210
Homepage URL
Email sikeo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Dept. of Respiratory Medicine, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization Kurashiki Central Hospital
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
Address
Tel
Email

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 倉敷中央病院(岡山県)、静岡県立静岡がんセンター(静岡県)、近畿中央胸部疾患センター(大阪府)、先端医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 20 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the prognostic impact of serum autoantibody (anti-CTLA-4 antibody, anti-PD-1 antibody, anti-BTLA antibody and anti-RPL29 antibody) in patients with extensive stage small cell lung cancer: a prospective multicenter registration study.

Management information
Registered date
2015 Year 03 Month 18 Day
Last modified on
2016 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019547

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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