UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044601 |
|---|---|
| Receipt number | R000050944 |
| Scientific Title | A prospective validation study of the serum biomarker for the stage diagnosis of superficial esophageal cancer |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/05/22 14:46:03 |
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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
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
tshimura@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050944
