UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012246
Receipt number R000014318
Scientific Title Evaluation of cumulative prognostic score based on fibrinogen and albumin in patients with esophageal cancer: multicenter prospective cohort study
Date of disclosure of the study information 2013/11/08
Last modified on 2022/01/27 12:24:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name