UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A quantification of circulating tumor cells in patients with gastric cancer by telomerase-specific oncolytic adenoviral agents
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroaki Ito, MD, PhD
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
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	Hiroaki Ito, MD, PhD
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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