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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000007892
Receipt No. 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

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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
Email

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/
Email swt@idac.tohoku.ac.jp

Sponsor
Institute Institute of Development, Aging and Cancer
Tohoku University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009277

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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