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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008925
Receipt No. R000010465
Scientific Title Sorting of circulating tumor cells from patients with esophageal cancer and genomic DNA extraction: a prospective feasibility study
Date of disclosure of the study information 2012/09/15
Last modified on 2019/09/26

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Basic information
Public title Sorting of circulating tumor cells from patients with esophageal cancer and genomic DNA extraction: a prospective feasibility study
Acronym DNA extraction from circulating tumor cells in esophageal cancer patients: a prospective feasibility study
Scientific Title Sorting of circulating tumor cells from patients with esophageal cancer and genomic DNA extraction: a prospective feasibility study
Scientific Title:Acronym DNA extraction from circulating tumor cells in esophageal cancer patients: a prospective feasibility study
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Laboratory medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We will sort circulating tumor cells from esophageal cancer patients and extract nucleotide. And, we will compare genomic analysis among circulating tumor cells, primary tumor and normal tissue.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Similarity of genomic mutation
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) histologically proven esophageal cancer
(2) age 20-80 years
(3) sufficient organ function
(4) written informed consent
Key exclusion criteria (1) synchronous or metachronous malignancy
(2) pregnant or breastfeeding women
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ito
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL 045-949-7000
Email h.ito@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Ito
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 224-8503
Address Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL 045-949-7000
Homepage URL
Email h.ito@med.showa-u.ac.jp

Sponsor
Institute Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Digestive Disease Center, Showa University Northern Yokohama 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 Showa University
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, JAPAN
Tel 03-3784-8022
Email m-rinri@ofc.showa-u.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

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 15 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 Completed
Date of protocol fixation
2012 Year 04 Month 05 Day
Date of IRB
2012 Year 04 Month 05 Day
Anticipated trial start date
2012 Year 06 Month 19 Day
Last follow-up date
2019 Year 09 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will sort circulating tumor cells from esophageal cancer patients and extract nucleotide. And, we will compare genomic analysis among circulating tumor cells, primary tumor and normal tissue.

Management information
Registered date
2012 Year 09 Month 15 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010465

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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