UMIN-CTR Clinical Trial

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

gastric cancer, esophageal cancer, soft tissue sarcoma

Classification by specialty

Gastroenterology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Institute of Development, Aging and Cancer
Tohoku University

Institute

Department

Personal name

Organization

subsidy of administrative cost

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

05

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

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