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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004026
Receipt No. R000004278
Scientific Title A quantification of circulating tumor cells in patients with gastric cancer by telomerase-specific oncolytic adenoviral agents
Date of disclosure of the study information 2010/08/10
Last modified on 2016/04/15

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Basic information
Public title A quantification of circulating tumor cells in patients with gastric cancer by telomerase-specific oncolytic adenoviral agents
Acronym A quantification of circulating tumor cells in gastric cancer patients by telomerase-specific oncolytic adenoviral agents
Scientific Title A quantification of circulating tumor cells in patients with gastric cancer by telomerase-specific oncolytic adenoviral agents
Scientific Title:Acronym A quantification of circulating tumor cells in gastric cancer patients by telomerase-specific oncolytic adenoviral agents
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will evaluate efficacy of quantification of circulating tumor cells in patients with gastric cancer by telomerase-specific oncolytic adenoviral agents, as clinical biomarker. Peripheral blood samples (7.5 ml) are obtained from the patients three times: before surgery, 4 weeks and 6 months after surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes measured value of circulating tumor cell (CTC)in peripheral blood, overall survival and relapse-free survival
Key secondary outcomes Tumor clinical factor, tumor pathological factor and patients background

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Measurement of circulating tumor cell (CTC) in peripheral blood from patients with gastric cancer
Interventions/Control_2 Measurement of circulating tumor cell (CTC) in peripheral blood from healthy volunteer
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 adenocarcinoma of the stomach by endoscopic biopsy
2)Clinical solitary tumor
3)No prior treatment of endoscopic resection, chemotherapy or radiation therapy
4)Aged between 20-80 years old
5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6)Sufficient organ function
7)Written informed consent
Key exclusion criteria 1)Synchronous or metachronous malignancy.
2)Pregnant women.
3)Breast-feeding women.
4)Active or chronic viral hepatitis.
5)Active bacterial or fungous infection.
6)Diabetes mellitus.
7)Systemic administration of corticosteroids.
8)Unstable hypertension.
Target sample size 200

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

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

Funding Source
Organization Digestive Disease Center, Showa University Nothern Yokohama Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor SYSMEX CORPORATION
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
2010 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 10 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004278

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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