UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Observational Study on Heterogeneous Carcinogenesis and carbohydrate deficient transferrin (CDT) after Endoscopic Treatment of Superficial Esophageal Cancer
Acronym	Prospective Observational Study on Heterogeneous Carcinogenesis and CDT after Endoscopic Treatment of Superficial Esophageal Cancer
Scientific Title	Prospective Observational Study on Heterogeneous Carcinogenesis and carbohydrate deficient transferrin (CDT) after Endoscopic Treatment of Superficial Esophageal Cancer
Scientific Title:Acronym	Prospective Observational Study on Heterogeneous Carcinogenesis and CDT after Endoscopic Treatment of Superficial Esophageal Cancer
Region	Japan

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

Objectives
Narrative objectives1	To clarify the association of carbohydrate deficient transferrin (CDT) with heterogeneous carcinogenesis after endoscopic treatment of superficial esophageal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association between CDT and Heterogeneous Head, Neck, and Esophageal Cancer
Key secondary outcomes	1)The association between CDT and other heterogeneous carcinogenesis 2)Risk factors for heterogeneous head, neck, and esophageal cancer 3)The association between CDT and content of drinking questionnaire

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)Between 20 and 85 years of age 2)Patients with a clinical or pathological diagnosis of superficial esophageal cancer 3)Written informed consent
Key exclusion criteria	1)Patients with metastases 2)Patients with piecemeal resection 3)Patients with residual cancer after endoscopic treatment 4)Patients with Positive or indifinite for vertical margin 5)Patients treated with radiotherapy or systemic chemotherapy after endoscopic resection 6)Patients with previous radiotherapy or chemotherapy 7)Patients with past history of cervical Surgery or esophagectomy or gastrectomy 8)Patients with non curative cancer in other organs
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Furukawa
Organization	Nara Medical University Hospital
Division name	Division of Endoscopy
Zip code	6348521
Address	840, Shijocho, Kashihara city, Nara, Japan
TEL	0744-22-3051
Email	furukawa@naramed-u.ac.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Furukawa
Organization	Nara Medical University Hospital
Division name	Division of Endoscopy
Zip code	6348521
Address	840, Shijocho, Kashihara city, Nara, Japan
TEL	0744-22-3051
Homepage URL
Email	furukawa@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University Hospital
Institute
Department

Funding Source
Organization	Nara Medical University Hospital
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	Nara Medical University Hospital
Address	840, Shijocho, Kashihara city, Nara, Japan
Tel	0744-22-3051
Email	furukawa@naramed-u.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	2021 Year 10 Month 20 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 04 Month 27 Day
Date of IRB	2021 Year 06 Month 29 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 10 Month 19 Day
Last modified on	2021 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052285