UMIN-CTR Clinical Trial

Basic information
Public title	Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Acronym	Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Scientific Title	Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Scientific Title:Acronym	Background Factors Inducing Genetic Aberrations in the Serrated Pathway Using Organoids
Region	Japan

Condition
Condition	colorectal serrated lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To analyze early-stage lesions of serrated pathway-derived cancers using organoids to elucidate the triggers of colorectal cancer development, including not only genetic abnormalities but also immune responses such as gut microbiota and cytokines.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Analysis of early-stage lesions of serrated pathway-derived cancers using organoids to elucidate factors necessary for the development of colorectal cancer, including genetic abnormalities and immune responses (gut microbiota and cytokines).
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with serrated colonic lesions (HP, SSL, TSA, unclassifiable, suspicious lesions included) evaluated by endoscopic diagnosis and underwent endoscopic or surgical treatment
Key exclusion criteria	(1) Lesions that cannot be classified according to the diagnostic criteria for serrated colon lesions (HP, SSL, and TSA) of the WHO classification (2) Patients who are judged by the principal investigator to be unsuitable as subjects In the event that the patient requests cancellation of participation.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Yoshii
Organization	Sapporo Medical University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	060-8543
Address	South1 West 16 Chuo-ku, Sapporo
TEL	816612111
Email	shinji-yoshii@sapmed.ac.jp

Public contact
Name of contact person	1st name Shinji Middle name Last name Yoshii
Organization	Sapporo Medical University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	060-8543
Address	South1 West 16 Chuo-ku, Sapporo
TEL	816612111
Homepage URL
Email	shinji-yoshii@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicine
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	Sapporo Medical University School of Medicine
Address	South1 West 16 Chuo-ku, Sapporo
Tel	816612111
Email	shinji-yoshii@sapmed.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	2020 Year 10 Month 15 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	Preinitiation
Date of protocol fixation	2020 Year 06 Month 14 Day
Date of IRB	2020 Year 09 Month 10 Day
Anticipated trial start date	2020 Year 09 Month 10 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The purpose of this study is to analyze early-stage lesions of serrated pathway-derived cancers using organoids, which provide an experimental environment similar to that of real patients, and to elucidate not only genetic abnormalities but also immune responses, including intestinal microbiota and cytokines, that are necessary for the development of colorectal cancer. This study is expected to be applied to new methods of prevention and drug discovery for colorectal cancer.

Management information
Registered date	2020 Year 10 Month 15 Day
Last modified on	2020 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048073