UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008997 |
|---|---|
| Receipt number | R000010553 |
| Scientific Title | Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the esophageal cancer patient |
| Date of disclosure of the study information | 2012/09/29 |
| Last modified on | 2012/09/28 11:58:21 |
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Basic information
Public title
Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the esophageal cancer patient
Acronym
Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the esophageal cancer patient
Scientific Title
Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the esophageal cancer patient
Scientific Title:Acronym
Examination of the usefulness as the tumor marker of the NY-ESO-1 antibody titer in the esophageal cancer patient
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analyze usefulness as the tumor marker of the NY-ESO-1 antibody titer of the esophageal cancer patient.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recurrence prediction by the NY-ESO-1 antibody titer in the esophageal cancer patients, with NY-ESO-1 antibody titer positive before surgery, that has been resected radically, NY-ESO-1 antibody titer was measured. We examine The recurrence rate of the NY-ESO-1 antibody-positive case of the first year after surgery.
Key secondary outcomes
1. NY-ESO-1 antibody titer positive rate
2. Incidence of the NY-ESO-1 antigen expression in the esphageal cancer tissue
3. Correlation between NY-ESO-1 antibody titer and prognosis
4. Correlation between expression of the NY-ESO-1 antigen and prognosis
5. Relations withNY-ESO-1 antibody titer and the effect of the chemotherapy
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed as esophageal cancer which are proven by biopsy as squamous cell carcinoma or adenocarinoma and can receive radical resection.
Key exclusion criteria
Synchronous or metachronous (within 5 years) malignancies
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University,Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita city, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University,Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita city, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka University,Graduate School of Medicine, Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 09 | Month | 29 | 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
| 2012 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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
not yet
Management information
Registered date
| 2012 | Year | 09 | Month | 28 | Day |
Last modified on
| 2012 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010553
