UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of outcomes and response to treatments with an ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Acronym	An ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Scientific Title	Prediction of outcomes and response to treatments with an ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Scientific Title:Acronym	An ultrasensitive method for assessing intratumor epigenetic heterogeneity in colorectal cancer
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To determine the clinical significance of the detection of epigenetic heterogeneity in primary tumor and plasma from colorectal cancer patients with Methylation-sensitive high resolution melt(MS-HRM).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detection rates of epigenetic heterogeneity in primary tumor and plasma from colorectal cancer patients with Methylation-sensitive high resolution melt(MS-HRM).
Key secondary outcomes	1.To investigate the diffenrences in the detection rates between quantitative methylation specific PCR (qMSP) and MS-HRM 2.To investigate the correlations between epigenetic heterogeneity and gene expression in primary tumor from colorectal cancer patients

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients are more than 20 and less than 80 years old 2.Patients without synchronous or metachronous multiple cancers 3.Eastern Cooperative Oncology Group performance status of 0, 1, or 2 4.Patients without severe complications (heart disease, liver disease, renal disease, infection) 5.All patients were required to give written informed consent prior to enrolment in the study
Key exclusion criteria	1.Patients do not meet the inclusion criteria 2.Patients without histologically confirmed cancer 3.Patients whom investigators consider to be ineligible
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Sakamoto
Organization	Juntendo University Faculty of Medicine
Division name	Department of Coloproctological Surgery
Zip code	113-8421
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111
Email	kazusaka@juntendo.ac.jp

Public contact
Name of contact person	1st name Kiichi Middle name Last name Sugimoto
Organization	Juntendo University Faculty of Medicine
Division name	Department of Coloproctological Surgery
Zip code	113-8421
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL	03-3813-3111
Homepage URL
Email	ksugimo@juntendo.ac.jp

Sponsor
Institute	Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization	Our institution
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	Juntendo University Faculty of Medicine
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel	03-3813-3111
Email	ksugimo@juntendo.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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 25 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	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 25 Day
Date of IRB	2016 Year 02 Month 19 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: Cohort study Patient enrollment: Patients who undergo surgery for colorectal cancer in our department from February 2016 to December 2017 Examination: Laboratory test (WBC, RBC, Plt, AST, ALT, T-Bil, Cre) as well as methylated DNA measurement

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024437