UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009564 |
|---|---|
| Receipt number | R000011220 |
| Scientific Title | Research on the Elucidation of the Prognostic Factor and Mechanism of Drug Resistance in Gastric Cancer Patients who Receive Systemic Chemotherapy. |
| Date of disclosure of the study information | 2012/12/17 |
| Last modified on | 2017/06/21 09:34:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on the Elucidation of the Prognostic Factor and Mechanism of
Drug Resistance in Gastric Cancer Patients who Receive Systemic Chemotherapy.
Acronym
Biomarker Study in Gastric Cancer
Patients with Primary Lesion.
Scientific Title
Research on the Elucidation of the Prognostic Factor and Mechanism of
Drug Resistance in Gastric Cancer Patients who Receive Systemic Chemotherapy.
Scientific Title:Acronym
Biomarker Study in Gastric Cancer
Patients with Primary Lesion.
Region
| Japan |
Condition
Condition
Gastric cancer patients with primary
lesion.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify biomarkers which correlate
with prognosis and drug resistance in
gastric cancer patients who receive
systemic chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Using biopsy specimens and blood samples
collected before and after systemic chemotherapy in gastric cancer patients
with primary lesion, we will try to identify biomarkers which lead to personalized medicine.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of prognostic factors
which correlate with tumor response.
Key secondary outcomes
Identification of prognostic factors
which correlate with survival.
Identification of biomarkers
which correlate with drug resistance.
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.Equal to or over 20 years.
2.Established diagnosis of typical
gastric cancer by histology or
cytology.
3.Target lesion(at least one lesion)
are detected by diagnostic imaing
performed within 4 weeks.
4.Patient who is planned to receive
systemic chemotherapy for advanced
gastric cancer.
5.Patient who is planned to evaluate
the expression of HER2.
6.Written informed concent can be
obtained.
Key exclusion criteria
1.Patients who need continuous anti-
coaglant therapy (impossible to
stop anti-coaglant therapy).
2.Patients who are considered to be
ineligible by referring physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Honma |
Organization
National Cancer Center Hospital in Japan
Division name
Department of Gastrointestinal Oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
yohonma@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Honma |
Organization
National Cancer Center Hospital in Japan
Division name
Department of Gastrointestinal Oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
yohonma@ncc.go.jp
Sponsor or person
Institute
Department of Gastrointestinal Oncology,
National Cancer Center Hospital in Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of health, labour and welfare
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2012-118
Org. issuing International ID_1
IRB of National Cancer Center Hospital in Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院(東京都)
National Cancer Center Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now recruiting
Management information
Registered date
| 2012 | Year | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011220
