UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004069 |
|---|---|
| Receipt number | R000004901 |
| Scientific Title | Biomarker Study for Personalized Anti-cancer Therapy in Gastrointestinal Cancer |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2020/08/26 13:52:39 |
* 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
Biomarker Study for Personalized Anti-cancer Therapy in Gastrointestinal Cancer
Acronym
Biomarker Study in Gastrointestinal Cancer
Scientific Title
Biomarker Study for Personalized Anti-cancer Therapy in Gastrointestinal Cancer
Scientific Title:Acronym
Biomarker Study in Gastrointestinal Cancer
Region
| Japan |
Condition
Condition
Esophageal Cancer, Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Biliary Tract Cancer,
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify plasma peptide biomarkers which correlate with adverse events or tumor response in chemotherapy for gastrointestinal cancer.
Basic objectives2
Others
Basic objectives -Others
Using plasma samples collected before start of chemotherapy, we will try to identify peptide biomarkers which correlate with adverse events or tumor response in chemotherapy for gastrointestinal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification and clinical application of predictors of tumor response and adverse events in GI cancer chemotherapy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer, and biliary tract cancer
2) Receiving cancer chemotherapy
3) No prior treatment with anti-cancer agents and radiation
4) Adequate organ function
5) Written informed consent
Key exclusion criteria
1) Chemoradiation except for esophageal cancer treatment
2) Active infectious disease
3) Ileus
4) Severe diarrhea
5) Interstitial pneumonia
6) Severe diabetes
7) Under treatment for unstable angina or myocardial infarction
8) Metastasis to central nervus system
9) Massive ascites or pleural effusion
10) Dementia
11) Other inappropriate cases according to primary doctor's evaluation
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4319
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Matsubara |
Organization
Kyoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3518
Homepage URL
jmatsuba@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University IRB
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
http://www.kyotocbrc.kuhp.kyoto-u.ac.jp/cbrc/about/
Number of participants that the trial has enrolled
100
Results
This research has been included into the projects in the Kyoto University Clinical Bio-resource Center.
Results date posted
| 2020 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in analysis
Management information
Registered date
| 2010 | Year | 08 | Month | 19 | Day |
Last modified on
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004901
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
