UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007892 |
|---|---|
| Receipt number | R000009277 |
| Scientific Title | Exploratory trial on sphingolipid for the discovery of novel cancer biomarker |
| Date of disclosure of the study information | 2012/05/07 |
| Last modified on | 2013/05/22 16:32:47 |
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Basic information
Public title
Exploratory trial on sphingolipid for the discovery of novel cancer biomarker
Acronym
Exploratory trial on sphingolipid for the discovery of novel cancer biomarker
Scientific Title
Exploratory trial on sphingolipid for the discovery of novel cancer biomarker
Scientific Title:Acronym
Exploratory trial on sphingolipid for the discovery of novel cancer biomarker
Region
| Japan |
Condition
Condition
gastric cancer, esophageal cancer, soft tissue sarcoma
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose in this study is an investigation for clinical usefulness on blood sphingosine-1-phosphoric acid (S1P) as novel cancer biomarker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We examine the utility of S1P as novel tumor marker.
Key secondary outcomes
We examine correlation between S1P value and response rate(RR), progression-free survival(PFS) and overall survival(OS).
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) confirmed gastric cancer, esophageal cancer or soft tissue sarcoma by histopathological diagnosis
2) inoperable and recurrent gastric cancer, esophageal cancer or soft tissue sarcoma, and those who are planned or performed chemotherapy
3) age: >=20
4) Performance status(ECOG) =0-2
5) Only the case who will survive three months or more from enrollment
6) written informed consent
Key exclusion criteria
1) with active infection (more than 38 degree)
2) with the following heart disorder or state
->A history of previous congestive heart failure
->High-risk cardiac arrhythmia that is impossible to control
->Clinical serious heart valve disease
->Hypertension (e.g. patients with systolic blood pressure> 180mmHg or diastolic blood pressure> 100mmHg)
3) with serious complications (interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure or diabetes mellitus inadequate control)
4) with active bleeding from gastric cancer, esophageal cancer or gastrointestinal ulcer
5) with multiple primary cancer keeping activity
6) receiving systemic steroid therapy continuously
7) A pregnant woman or woman with pregnant possibility
8) Doctor's decision not to be registered to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikashi Ishioka |
Organization
Institute of Development, Aging and Cancer
Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8543
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Takahashi |
Organization
Institute of Development, Aging and Cancer Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
TEL
022-717-8543
Homepage URL
http://www.co.idac.tohoku.ac.jp/
swt@idac.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
subsidy of administrative cost
Organization
Division
Category of Funding Organization
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
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 | 05 | Month | 07 | 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
Suspended
Date of protocol fixation
| 2012 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine the utility of S1P as novel tumor marker.We especially examine correlation between S1P value and response rate(RR), progression-free survival(PFS) and overall survival(OS).
Management information
Registered date
| 2012 | Year | 05 | Month | 06 | Day |
Last modified on
| 2013 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009277
