UMIN-CTR Clinical Trial

Basic information
Public title	Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer
Acronym	Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer
Scientific Title	Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer
Scientific Title:Acronym	Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer
Region	Japan

Condition
Condition	Small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer
Basic objectives2	Others
Basic objectives -Others	Genomic Analysis of Circulating Tumor Cells in Patients with Small Cell Lung Cancer
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	genomic analysis of circulating tumor cells in patients with small cell lung cancer by collecting blood samples at pre-, and post- treatment.
Key secondary outcomes

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	patients newly diagnosed as having SCLC and starting chemotherapy or chemoradiotherapy
Key exclusion criteria	<20 years old
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yamaoka Toshimitsu
Organization	Showa University
Division name	institute of molecular oncology
Zip code
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8146
Email	yamaoka.t@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yamaoka Toshimitsu
Organization	Showa University
Division name	institute of molecular oncology
Zip code
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8146
Homepage URL
Email	yamaoka.t@med.showa-u.ac.jp

Sponsor
Institute	Yamaoka Toshimitsu
Institute
Department

Funding Source
Organization	Showa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Center for Antibody and Vaccine Therapy, Research Hospital, The Institute of Medicine, University of Tokyo
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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 09 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	Terminated
Date of protocol fixation	2015 Year 11 Month 09 Day
Date of IRB	2015 Year 10 Month 28 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2019 Year 11 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	patients with small cell lung cancer met the inclusion criteria and were prospectively enrolled between November 2015 and September 2018.

Management information
Registered date	2015 Year 11 Month 06 Day
Last modified on	2019 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022725