UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025542 |
|---|---|
| Receipt number | R000029405 |
| Scientific Title | Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the highly sensitive fluorescence immunostaining |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2017/01/05 16:13:26 |
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Basic information
Public title
Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the highly sensitive fluorescence immunostaining
Acronym
Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the highly sensitive fluorescence immunostaining
Scientific Title
Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the highly sensitive fluorescence immunostaining
Scientific Title:Acronym
Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the highly sensitive fluorescence immunostaining
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the histopathological examination with the expression of various cancer-related factors using the high sensitive fluorescence immunostaining
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between various cancer-related factors and progress-free survival period
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Squamous cell carcinoma, adenosquamous cell carcinoma or basaloid carcinoma
2) Resectable disease
3) Clinical stage I, II or III excluding T4b disease (UICC tumor, node, metastasis system TNM classification)
4) Age 20 to 85 years
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
6) No previous surgery for esophageal cancers
7) No previous chemo- or radiotherapy for any malignancies
8) Sufficient organ function
9) Written informed consent
Key exclusion criteria
1) Other primary cancer
2) Psychiatric disease
3) Serious complications
4) Cardiovascular disease or heart failure occur within 3 months
5) Cerebrovascular disease occur within 3 months
6) Active infection
7) With cardiac pacemaker or defibrillator
8) Positive for hepatitis B virus antigen
9) Pregnancy
10) Others who are inadequate to entry this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamei |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
Address
Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Kamei |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
Address
Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
TEL
022-717-7214
Homepage URL
tkamei@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 01 | Month | 05 | 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
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2017 | Year | 01 | Month | 05 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029405
| Research Plan | |
|---|---|
| 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 |
