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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036884
Receipt No. R000042031
Scientific Title Exploratory analysis of biomarkers predicting the treatment response and the prognosis in patients with esophageal carcinoma
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/29

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Basic information
Public title Exploratory analysis of biomarkers predicting the treatment response and the prognosis in patients with esophageal carcinoma
Acronym Analysis of biomarkers predicting the treatment response and the prognosis in esophageal cancer
Scientific Title Exploratory analysis of biomarkers predicting the treatment response and the prognosis in patients with esophageal carcinoma
Scientific Title:Acronym Analysis of biomarkers predicting the treatment response and the prognosis in esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Identification of factors involved in the treatment response or the prognosis by investigating the treatment results and survival in patients with esophageal cancer
Basic objectives2 Others
Basic objectives -Others Basic research
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of factors involved in the the treatment response or the prognosis
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with esophageal cancer confirmed by histological examination
Key exclusion criteria metastatic esophageal tumor
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Ohnuma
Organization Sapporo Medical University School of Medicine
Division name Department of Medical Oncology
Zip code 060-8543
Address S-1,W-16, Chuo-ku, Sapporo
TEL 011-611-2111
Email ohnuma@sapmed.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Ohnuma
Organization Sapporo Medical University School of Medicine
Division name Department of Medical Oncology
Zip code 060-8543
Address S-1,W-16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email ohnuma@sapmed.ac.jp

Sponsor
Institute Department of Medical Oncology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Oncology, Sapporo Medical University School of Medicine
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 Sapporo Medical University
Address S-1,W-16, Chuo-ku, Sapporo
Tel 011-611-2111
Email ji-rskk@sapmed.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
2019 Year 05 Month 30 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
2019 Year 05 Month 16 Day
Date of IRB
2019 Year 05 Month 16 Day
Anticipated trial start date
2019 Year 05 Month 16 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Identification of factors involved in the treatment response or the prognosis by investigating the treatment results and survival in patients with esophageal cancer

Management information
Registered date
2019 Year 05 Month 29 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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