UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of cumulative prognostic score based on fibrinogen and albumin in patients with esophageal cancer: multicenter prospective cohort study
Acronym	Fibrinogen and albumin score in esophageal cancer patients: prospective cohort study
Scientific Title	Evaluation of cumulative prognostic score based on fibrinogen and albumin in patients with esophageal cancer: multicenter prospective cohort study
Scientific Title:Acronym	Fibrinogen and albumin score in esophageal cancer patients: prospective cohort study
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical utility of fibrinogen and albumin as prognostic factors in esophageal cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease free survival rate, overall survival rate
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Older than 20 years old 2. Histologically diagnosed as Esophageal cancer 3. Undergo treatment of esophageal cancer (Esophagectomy, Eondoscopic resection, Chemoradiotherapy) 4. No previous treatment for Esophageal cancer 5. Provide informed consent
Key exclusion criteria	1. Diagnosed as advanced cancer in past 5 years 2. Severe liver abnormalities
Target sample size	620

Research contact person
Name of lead principal investigator	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	hkawakubo@z3.keio.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Kawakubo
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	hkawakubo@z3.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio 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	Keio University School of Medicine, Ethics Committee
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel	03-5363-3503
Email	med-rinri-jimu@adst.keio.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	2013 Year 11 Month 08 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	Completed
Date of protocol fixation	2013 Year 10 Month 28 Day
Date of IRB	2013 Year 09 Month 28 Day
Anticipated trial start date	2013 Year 11 Month 01 Day
Last follow-up date	2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Investigate the utility of fibrinogen and albumin as a prognostic factor in esophageal cancer patients.

Management information
Registered date	2013 Year 11 Month 08 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014318