UMIN-CTR Clinical Trial

Basic information
Public title	The HGCSG1901 Study; Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of IRIS/Bev in Patients with Metastatic Colorectal Cancer.
Acronym	HGCSG1901
Scientific Title	The HGCSG1901 Study; Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of IRIS/Bev in Patients with Metastatic Colorectal Cancer.
Scientific Title:Acronym	HGCSG1901
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy, safety and efficacy predictors of daily practice use of IRIS/Bev for patients with metastatic or unresectable colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall Survival, Response rate, Disease control rate, Safety, Analysis by UGT1A1 polymorphism, Treatment effect predictor, Examination of prognostic factors

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)Patients who were treated with IRIS / Bev in primary or secondary treatment. 2)Age <=20 years old at the time of diagnosis. 3)patients who have not rejected the participation of this study from the research subjects or their agent(person who is thought to be able to speak for the will and interest of the research subject).
Key exclusion criteria	1)Participation in the clinical trial is determined as unsuitable.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Yoshito Middle name Last name Komatsu
Organization	Hokkaido University Hospital
Division name	Cancer Center
Zip code	060-8648
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email	ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Ken Middle name Last name Ito
Organization	Hokkaido University Hospital
Division name	Cancer Center
Zip code	060-8648
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Homepage URL
Email	kenito0421@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Gastrointestinal Cancer Study Group
Institute
Department

Funding Source
Organization	Hokkaido Gastrointestinal Cancer Study Group
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	Clinical Research and Medical Innovation Center, Hokkaido University Hospital
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	KKR札幌医療センター（北海道）、NTT東日本札幌病院（北海道）、秋田赤十字病院（秋田県）、岩見沢市立総合病院（北海道）、帯広厚生病院（北海道）、北見赤十字病院（北海道）、釧路ろうさい病院（北海道）、恵佑会札幌病院（北海道）、佐野病院（兵庫県）、市立秋田総合病院（秋田県）、市立札幌病院（北海道）、市立函館病院（北海道）、手稲渓仁会病院（北海道）、斗南病院（北海道）、苫小牧市立病院（北海道）、苫小牧日翔病院（北海道）、富山赤十字病院（富山県）、富山大学附属病院（富山県）、函館中央病院（北海道）、弘前大学医学部附属病院（青森県）、北海道医療センター（北海道）、北海道がんセンター（北海道）、北海道大学病院（北海道）、三沢市立三沢病院（青森県）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 08 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	415
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	2019 Year 09 Month 09 Day
Date of IRB	2019 Year 12 Month 13 Day
Anticipated trial start date	2019 Year 12 Month 13 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information	Retrospective Cohort Study

Management information
Registered date	2020 Year 01 Month 07 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044566

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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