UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029465
Receipt No. R000033668
Scientific Title Subtype Classification Consortium for Esophageal Squamous cell carcinoma Sensitivity of CROC study (UMIN000008086)
Date of disclosure of the study information 2017/10/11
Last modified on 2017/10/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Chikatoshi Katada
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
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
Middle name
Last name Chikatoshi Katada
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
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
Address
Tel
Email

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
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
2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
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
2017 Year 10 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.