UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025319 |
|---|---|
| Receipt number | R000028344 |
| Scientific Title | The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer |
| Date of disclosure of the study information | 2016/12/19 |
| Last modified on | 2017/05/13 18:27:35 |
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Basic information
Public title
The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer
Acronym
EGJ_CA_Study
Scientific Title
The study to investigate clnicopathological characteristics of superficial esophagogastro junction cancer
Scientific Title:Acronym
EGJ_CA_Study
Region
| Japan |
Condition
Condition
Esophagogastro junction cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify clinicaopthological characteristics of superficial esophagogastro junction cancer
Basic objectives2
Others
Basic objectives -Others
Biocharacteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of clinicaopthological characteristics of superficial esophagogastro junction cancer according to presence and absence of endoscopic gastric corpus mucosal atrophy
Key secondary outcomes
1) Factors associated with endoscopic gastric corpus mucosal atrophy
2) Difference of clinicaopthological characteristics of superficial esophagogastro junction cancer according to presence and absence of Barrett mucosa
3) Difference of clinicaopthological characteristics between EGJ cancer and Barrett cancer
4) Difference of clinicaopthological characteristics between EGJ cancer and gastric cancer in the upper body.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Siewert type 2 cancer (true cardia cancer: adenocarcinoma located within 1 cm above and 2 cm below the GE Junction)
2) pathological T1
Key exclusion criteria
1) Unevaluable endoscopic images
2) Unevaluable histological findings
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noiya Uedo |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL
06-6972-1181
uedou-no@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Katayama |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-3, Nakamichi 1-chome, Higashinari-ku, Osaka, Japan
TEL
06-6972-1181
Homepage URL
kbyori01@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design is a retrospective cross-sectional study.
Patients' data who treated in following Japanese institutions during 2010-2015 and met inclusion criteria were retrieved:
1) Cancer Institute Hospital of Japanese Foundation for Cancer Research, 2) Keio University Hospital, 3) Nagaoka Red Cross Hospital, 4) National Cancer Center Central Hospital, 5) National Cancer Center Hospital East, 6) Osaka Medical Center for Cancer and Cardiovascular Diseases, 7) Teine Keijinkai Hospital, 8) Tohoku University Hospital
Management information
Registered date
| 2016 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028344
