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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029649
Receipt No. R000033877
Scientific Title Prospective observational study for elderly people assessment tool for patients with resectable stage thoracic esophageal squamous cell carcinoma of the elderly (over 70 years old)
Date of disclosure of the study information 2018/01/01
Last modified on 2018/04/23

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Basic information
Public title Prospective observational study for elderly people assessment tool for patients with resectable stage thoracic esophageal squamous cell carcinoma of the elderly (over 70 years old)
Acronym Elderly esophageal cancer prospective observation
Scientific Title Prospective observational study for elderly people assessment tool for patients with resectable stage thoracic esophageal squamous cell carcinoma of the elderly (over 70 years old)
Scientific Title:Acronym Elderly esophageal cancer prospective observation
Region
Japan

Condition
Condition Thoracic esophageal squamous cell carcinoma
Classification by specialty
Medicine in general Gastroenterology Geriatrics
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, we conducted an elderly assessment for elderly patients with resectable thoracic esophageal squamous cell carcinoma (UICC 7 version: Stage II / III excluding T4) and were able to resect each of the thoracic esophageal squamous cell carcinomas in clinical stage. It is to gather basic data of the assessment tool and clarify the screening situation of treatment. We also explore the relationship between the elderly assessment and the adverse events and turning points of the selected treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of serious adverse event
Key secondary outcomes Survival by treatment group, survival by elderly people assessment, percentage of adverse events by elderly people assessment

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) over 70 years old
2) Pathologically proven squamous cell carcinoma of thoracic esophageal squamous cell carcinoma
3) Clinical stage cStage IB / II / III (excluding T4) in TNM classification (UICC-TNM 7th edition).
(Ut, Mt, Lt has tumor-major occupation site, permits infiltration into the neck and abdomen)
4) First treatment scheduled to be implemented at the institution
5) Consent has been obtained in the sentences of the subject person or of an adult family member
Key exclusion criteria None
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization Keio University, School of Medicine
Division name Keio Cancer Center
Zip code
Address 35, Shinanamachi, Shinjukuku, Tokyo, Japan
TEL 03-3353-1211
Email kitagawa@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Hamamoto
Organization Keio University, school of medicine
Division name Keio Cancer Center
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email yashmmt1971@gmail.com

Sponsor
Institute Keio University School 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 慶應義塾大学医学部 腫瘍センター

Other administrative information
Date of disclosure of the study information
2018 Year 01 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
None
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
2017 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information None

Management information
Registered date
2017 Year 10 Month 21 Day
Last modified on
2018 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033877

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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