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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017595
Receipt No. R000020393
Scientific Title Studies on the stability of the plasma substance P of patients administrated gastrointestinal cancer chemotherapy
Date of disclosure of the study information 2015/05/18
Last modified on 2015/11/18

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Basic information
Public title Studies on the stability of the plasma substance P of patients administrated gastrointestinal cancer chemotherapy
Acronym SP-01
Scientific Title Studies on the stability of the plasma substance P of patients administrated gastrointestinal cancer chemotherapy
Scientific Title:Acronym SP-01
Region
Japan

Condition
Condition Gastrointestinal cancer
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Measuring changes in plasma substance P concentration as a function of time that it took to freezing of the blood collected from patients administrated anti-cancer chemotherapy
Basic objectives2 Others
Basic objectives -Others Biological dynamics
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of change in time and substance P measurements taken from sample collection to separation and frozen
Key secondary outcomes

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 Patient age of 20 years or older at the time of obtaining informed consent.
Patients after receiving a sufficient explanation Upon participation in this study, on the thorough understanding, that document consent is obtained by the free will of the patient himself.
Patients who received the chemotherapy containing oxaliplatin or irinotecan against gastrointestinal cancer.
Key exclusion criteria Patients principal investigator or research personnel was judged unsuitable as subjects
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita14, Nishi5, Kita-ku, Sapporo City, Hokkaido, Japan
TEL +81-11-716-1161
Email tmuranaka@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuhito Muranaka
Organization Department of Gastroenterology and Hepatology
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita14, Nishi5, Kita-ku, Sapporo City, Hokkaido, Japan
TEL +81-11-716-1161
Homepage URL
Email tmuranaka@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University, Graduate School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Hokkaido University, Graduate School of Medicine, Department of Medicine, Division of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 05 Month 18 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 Terminated
Date of protocol fixation
2015 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 18 Day
Last follow-up date
2015 Year 07 Month 13 Day
Date of closure to data entry
2015 Year 07 Month 13 Day
Date trial data considered complete
2015 Year 07 Month 13 Day
Date analysis concluded
2015 Year 07 Month 13 Day

Other
Other related information Observation test

Management information
Registered date
2015 Year 05 Month 15 Day
Last modified on
2015 Year 11 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020393

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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