UMIN-CTR Clinical Trial

Basic information
Public title	Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity of CROC study (UMIN000008086)
Acronym	CROC-G study
Scientific Title	Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity of CROC study (UMIN000008086)
Scientific Title:Acronym	CROC-G study
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To do subtype classification of esophageal cancer by profiling the gene expression of pretreatment biopsy sample
Basic objectives2	Others
Basic objectives -Others	Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subtype classification of esophageal cancer
Key secondary outcomes	Correlation between subtype classification and curative effects

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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Diagnosed squamous cell carcinoma by endoscopic biopsy. 2) Confirmed the lesion of thoracic esophagus (An accessory lesion of EMR absolute criteria may not be localized thoracic esophagus). 3) Clinical stage II/III without T4 in TNM classification (UICC6th). 4) Age more than 20years and less than 75 years. 5) PS(ECOG) of 0 or 1. 6) No previous treatment expect endoscopic resection of esophageal cancer. 7) No previous chemotherapy or radiation therapy for other malignancy. 8) No severe organ failure. 9) Possibility of transthoracic and/or transabdominal curative resection of esophageal cancer. 10) Signed informed consent of the patient for the registration.
Key exclusion criteria	1) An active malignancy other than carcinoma in situ or mucosal carcinoma or a history of other malignancy within the past 5 years. 2) Women who are pregnant, lactating, or wish to become pregnant. 3) Unsuitable mental status and condition for clinical trials. 4) Received continuous steroids (orally or intravenous) administration. 5) Positive HBs antigen. 6) Unstable diabetes mellitus with oral hypoglycemic agent or insulin. 7) Acute myocardial infarction within the past 3 months. 8) Severe complications (COPD, interstitial lung disease, pulmonary fibrosis, heart failure and so on) . 9) Active bacterial or fungous infection(body temperature more than 38.5 degrees and proved bacterial infection by diagnostic imaging or bacteriological examination ) . 10) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Chikatoshi Middle name Last name Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato, Sagamihara, Kanagawa, 252-0374, Japan
TEL	042-778-8111
Email	ckatada@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Chikatoshi Middle name Last name Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato, Sagamihara, Kanagawa, 252-0374, Japan
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical research review board of the Kitasato Institute
Address	1-15-1 Kitasato, Minami, Sagamihara, Japan.
Tel	042-778-8111
Email	rinrib@med.kitasato-u.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	2017 Year 10 Month 11 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	71
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	2017 Year 09 Month 20 Day
Date of IRB	2012 Year 04 Month 18 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2022 Year 12 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	For CROC trial (UMIN000008086) patients

Management information
Registered date	2017 Year 10 Month 07 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033668