UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029649 |
|---|---|
| Receipt number | 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 | 2022/08/16 14:42:29 |
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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 | Yuko |
| Middle name | |
| Last name | Kitagawa |
Organization
Keio University, School of Medicine
Division name
Keio Cancer Center
Zip code
1608582
Address
35, Shinanamachi, Shinjukuku, Tokyo, Japan
TEL
03-3353-1211
kitagawa@a3.keio.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Hamamoto |
Organization
Keio University, school of medicine
Division name
Keio Cancer Center
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
yashmmt1971@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
Keio University School of Medicine
Address
35, Shinanomachi, Shinjukuku, Tokyo, Japan
Tel
03-3353-1211
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
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
60
Results
None
Results date posted
| 2022 | Year | 08 | Month | 16 | Day |
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 10 | Month | 21 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.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 |
| 2022/08/16 | E-choice：解析データ（固定用データ）20220802.xlsx |
