UMIN-CTR Clinical Trial

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
Email	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
Email	s.sugimoto@keio.jp

Sponsor
Institute	Keio University school of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043198