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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017700
Receipt No. R000020481
Scientific Title The retrospective study on elderly colon cancer patient about the change of the treatment and prognostic relationship.
Date of disclosure of the study information 2015/05/27
Last modified on 2015/05/27

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Basic information
Public title The retrospective study on elderly colon cancer patient about the change of the treatment and prognostic relationship.
Acronym The retrospective study on elderly colon cancer patient
Scientific Title The retrospective study on elderly colon cancer patient about the change of the treatment and prognostic relationship.
Scientific Title:Acronym The retrospective study on elderly colon cancer patient
Region
Japan

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

Objectives
Narrative objectives1 We will investigate the changes such as the therapeutic methods in the elderly person colon cancer cases (70 years old or older) in our department and a prognostic relationship as a backward retrospective study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Survival
Key secondary outcomes Disease Free Survival

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
70 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1 The case is a 70 years old or older on the chemotherapy starting date supporting after operation.
2 The case that is StageII high risk or III and diagnosed colon cancer histologically
3 The case that the treatment except the operation is not provided for a target disease
4 The case that enforced supporting chemotherapy after operation.t
5 The case that PS was 0-2 at the time of an adjuvant chemo therapy starting.
Key exclusion criteria 1 The case that it faced each other other than a target disease, and an operation was carried out
2 In addition, the case that a study person in charge judged to be inappropriate as a subject
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Sakamoto
Organization Juntendo University, Faculty of Medicine
Division name Department of Coloproctological Surgery,
Zip code
Address 3-1-3 Hongou, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kazusaka@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazumasa kure
Organization Juntendo University, Faculty of Medicine
Division name Department of Coloproctological Surgery,
Zip code
Address 3-1-3 Hongou, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kazusaka@juntendo.ac.jp

Sponsor
Institute Department of Coloproctological Surgery, Juntendo University, Faculty of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 05 Month 27 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 Preinitiation
Date of protocol fixation
2015 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retorospective study

Management information
Registered date
2015 Year 05 Month 27 Day
Last modified on
2015 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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