UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004026 |
|---|---|
| Receipt number | 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 09:17:49 |
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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
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
h.ito@showa-u.ac.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Nothern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004278
