UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathological biomarker search for the radiotherapy convalescence prediction factor of the esophageal cancer by the highly sensitive fluorescence immunostaining
Title of the study (Brief title)	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	Takashi Kamei
Organization	Tohoku University
Division name	Department of Surgery
Address	Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
TEL	022-717-7214
Email	tkamei@med.tohoku.ac.jp

Public contact
Name of contact person	Takashi Kamei
Organization	Tohoku University
Division name	Department of Surgery
Address	Seiryo-machi 1-1, Aobaku, Sendai,JAPAN
TEL	022-717-7214
Homepage URL
Email	tkamei@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029405