UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037904 |
|---|---|
| Receipt number | R000043198 |
| Scientific Title | Validation study of colorectal cancer treatment effect prediction by metabolomic markers |
| Date of disclosure of the study information | 2019/09/03 |
| Last modified on | 2021/09/30 10:37:56 |
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Basic information
Public title
Validation study of colorectal cancer treatment effect prediction by metabolomic markers
Acronym
Validation study of colorectal cancer treatment effect prediction by metabolomic markers
Scientific Title
Validation study of colorectal cancer treatment effect prediction by metabolomic markers
Scientific Title:Acronym
Validation study of colorectal cancer treatment effect prediction by metabolomic markers
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To varidate the colorectal cancer response predictive formula which use the pretreatment serum metabolite markers by comparing the predicted response and observed response of FOLFOX + BV or CapeOX + BV for the chemotherapy naive patient with measurable region by prospective observational study.
Basic objectives2
Others
Basic objectives -Others
Observation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Best clinical response (RECIST 1.1)
Serum concentration of metabolomic markers
Key secondary outcomes
Overall survival
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.Histopathologically confirmed colorectal cancer
2.Curatively unresectable colorectal cancer
3.Patient who has measurable lesion(s)
4.Without prior chemotherapy
5.Performance status is 0 or 1
6.Primary organ function is maintained
7.Written informed consent for participation in the study is obtained prior to the study
Key exclusion criteria
1.A case with double cancer
2.Patient who need additional drugs which affect the evaluation of anti-tumor effects of FOLFOIX +BV or CapeOX + BV.
3.Patients who are judged inappropriate by physician
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanigawara |
Organization
Keio university school of medicine
Division name
Department of Clinical pharmacokinetics and pharmacodynamics
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
81-3-5363-3706
tanigawara@a7.keio.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Sugimoto |
Organization
Keio university school of medicine
Division name
Department of Clinical pharmacokinetics and pharmacodynamics
Zip code
81-3-5363-3706
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
81-3-5363-3706
Homepage URL
s.sugimoto@keio.jp
Sponsor or person
Institute
Keio University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Keio university school of medicine
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
Keio University School of Medicine Ethics Review Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
81-3-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学 医学部（東京都）
愛知県がんセンター（愛知県）
四国がんセンター（愛媛県）
静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 03 | 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
44
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
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
The serum metabolite markers concentration of each patient before the start of treatment are measured, then calculate the individual patient's responder probability of the chemotherapy by the response prediction equation.
Compare the predicted response with the observed anti-tumor effect.
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043198
