UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Extensive-Stage Small-Cell Lung Cancer
Title of the study (Brief title)	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	Hiroshige Yoshioka
Organization	Kurashiki Central Hospital
Division name	Dept. of Respiratory Medicine
Address	1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL	086-422-0210
Email	hirotin@kchnet.or.jp

Public contact
Name of contact person	Satoshi Ikeo
Organization	Kyoto University Hospital
Division name	Dept. of Respiratory Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 02 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019547