UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029465 |
|---|---|
| Receipt number | 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 | 2021/10/13 21:44:28 |
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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
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
ckatada@med.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033668
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
