UMIN-CTR Clinical Trial

Basic information
Public title	Serum biomarker study for superficial esophageal cancer
Acronym	E-bio study
Scientific Title	A prospective validation study of the serum biomarker for the stage diagnosis of superficial esophageal cancer
Scientific Title:Acronym	E-bio study
Region	Japan

Condition
Condition	superficial esophageal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prospective validation of the serum biomarker for the stage diagnosis of superficial esophageal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of the serum biomarker for the stage diagnosis (squamous cell carcinoma)
Key secondary outcomes	1. Accuracy of the serum biomarker for the stage diagnosis (adenocarcinoma) 2. Sensitivity, specificity, PPV and NPV of the serum biomarker for surgical indication 3. Comparison between the serum biomarker and endoscopic diagnosis for the accuracy of the stage diagnosis 4. Accuracy, sensitivity, specificity, PPV and NPV by combining the serum biomarker and endoscopic diagnosis 5. Comparison between the combination biomarker and endoscopy alone for the accuracy of the stage diagnosis 6. Assessment of the tissue biomarkers

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.Either "histologically confirmed high grade intraepithelial neoplasia, squamous cell carcinoma, or adenocarcinoma" or "endoscopically diagnosed as esophageal cancer" 2.Clinically diagnosed as T1 stage, superficial esophageal cancer 3.20 years old =< age =< 85 years old 4.PS:0-2 5.Plan of endoscopic or surgical tumor resection 6.Written informed consent
Key exclusion criteria	1.Patients with other active malignancies 2.Difficulty of tumor resection due to poor physical condition 3.Patients who will be treated by radiation therapy, chemotherapy or argon plasma coagulation therapy. 4.Patients with severe mental disorder and dementia 5.Investigator's decision
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takaya Middle name Last name Shimura
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8211
Email	tshimura@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Okuda
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8211
Homepage URL
Email	tshimura@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

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	Clinical Research Management Center, Nagoya City University Hospital
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
Tel	052-858-7215
Email	clinical_research@med.nagoya-cu.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	名古屋市立大学病院（愛知県）、愛知医科大学病院（愛知県）、名古屋第二赤十字病院（愛知県）、春日井市民病院（愛知県）、岐阜県立多治見病院（岐阜県）、名古屋市立大学医学部附属東部医療センター（愛知県）、名古屋市立大学医学部附属西部医療センター（愛知県）、豊川市民病院（愛知県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 01 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	2021 Year 06 Month 15 Day
Date of IRB	2021 Year 09 Month 17 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter collaborative, prospective observational study

Management information
Registered date	2021 Year 06 Month 20 Day
Last modified on	2022 Year 05 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050944