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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039077
Receipt No. R000044566
Scientific Title The HGCSG1901 Study; Multicenter Retrospective Cohort Study Evaluating the Efficacy and Safety of IRIS/Bev in Patients with Metastatic Colorectal Cancer.
Date of disclosure of the study information 2020/01/08
Last modified on 2021/01/07

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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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