UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.
Acronym	A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.
Scientific Title	A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.
Scientific Title:Acronym	A Multicenter Retrospective Cohort Study to investigate the clinical significance of CA125 in the posterior line chemotherapy for unresectable advanced/recurrent colorectal cancer.
Region	Japan

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

Objectives
Narrative objectives1	To review the clinical significance of CA125 in the posterior line of chemotherapy for unresectable advanced/recurrent colorectal cancer in daily clinical practice.
Basic objectives2	Others
Basic objectives -Others	the clinical significance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Overall Survival, Response rate, Disease control rate, Search for treatment effect predictor and prognostic predictors, treatment effect on ascites

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 of colorectal cancer who were treated with FTD/TPI or Regorafenib.(Patients who received both FTD/TPI and regorafenib in the same case and met other inclusion/exclusion criteria should be enrolled for each treatment.) 2)Patients who have been tested for CA125 within 28 days prior to the start of the above treatment. 3)Age <=20 years old at the time of diagnosis. 4)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	100

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Yuki
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	060-8648
Address	Kita-14, Nishi-5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email	satoshi-yuuki175@joy.ocn.ne.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	Department of Gastroenterology and Hepatology, Hokkaido University Hospital
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	石川県立中央病院(石川県)、富山赤十字病院(富山県)、糸魚川総合病院(新潟県)、高岡市民病院(富山県)、富山厚生連高岡病院(富山県)、宮崎大学(宮崎大学)、霧島市立医師会医療センター(鹿児島県)、古賀総合病院(宮崎県)、手稲渓仁会病院(北海道)、NTT東日本札幌病院(北海道)、函館中央病院(北海道)、秋田大学医学部付属病院(秋田県)、秋田赤十字病院(秋田県)、市立秋田総合病院(秋田県)、北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 06 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	Open public recruiting
Date of protocol fixation	2020 Year 03 Month 24 Day
Date of IRB	2020 Year 03 Month 31 Day
Anticipated trial start date	2020 Year 04 Month 06 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective Cohort Study

Management information
Registered date	2020 Year 04 Month 04 Day
Last modified on	2020 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045669

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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