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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003333
Receipt No. R000004043
Scientific Title Evaluation of circulating tumor cells in small cell lung cancer patients
Date of disclosure of the study information 2010/03/13
Last modified on 2014/02/15

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Basic information
Public title Evaluation of circulating tumor cells in small cell lung cancer patients
Acronym Circulating tumor cells in small cell lung cancer
Scientific Title Evaluation of circulating tumor cells in small cell lung cancer patients
Scientific Title:Acronym Circulating tumor cells in small cell lung cancer
Region
Japan

Condition
Condition Small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between CTCs and efficacy of treatment or prognosis
Basic objectives2 Others
Basic objectives -Others To evaluate the relationship between CTCs and tumor markers
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between CTC counts and response rate or survival time
Key secondary outcomes Relationship between CTC counts and tumor markers

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. Histologically or cytologically proven small cell lung cancer
2. Chemotherapy and/or radiation are planned to initiate
3. Informed consent is obtained
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tateaki Naito
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL +81-55-989-5222
Email t.naito@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tateaki Naito
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL +81-55-989-5222
Homepage URL http://www.scchr.jp/
Email t.naito@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Shizuoka Cancer Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of thoracic surgery, Hyogo Collage of Medicine
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 静岡県立静岡がんセンター(静岡県)、兵庫医科大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prognostic impact of circulating tumor cells in patients with small cell lung
cancer. J Thorac Oncol. 2012 Mar;7(3):512-9.
Naito T, Tanaka F, Ono A, Yoneda K, Takahashi T, Murakami H, Nakamura Y, Tsuya A, Kenmotsu H, Shukuya T, Kaira K, Koh Y, Endo M, Hasegawa S, Yamamoto N.

Management information
Registered date
2010 Year 03 Month 13 Day
Last modified on
2014 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004043

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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