UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020996 |
|---|---|
| Receipt number | R000023931 |
| Scientific Title | Long-term quality-of-life evaluation in patients after Esophagectomy by EORTC QLQ-OES and C-30 |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2018/01/31 22:33:14 |
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Basic information
Public title
Long-term quality-of-life evaluation
in patients after Esophagectomy
by EORTC QLQ-OES and C-30
Acronym
The QOL evaluation in patients after esophagectomy
Scientific Title
Long-term quality-of-life evaluation
in patients after Esophagectomy
by EORTC QLQ-OES and C-30
Scientific Title:Acronym
The QOL evaluation in patients after esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the quality-of-life in patients after Esophagectomy by EORTC QLQ-OES and C-30
Basic objectives2
Others
Basic objectives -Others
To clarify the effect of surgical approach, reconstruction route, and other clinico-pathological factors on QOL.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
aw scores of each QOL questionnaire (EORTC QLQ-OES and C-30)and VAS
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients underwent subtotal esophagectomy for esophageal cancer
2) Provided written informed consent
Key exclusion criteria
1) Considered inadequate for inclusion in this trial by the physician
2) Patients without consent for enrollment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Koike |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery (Surgery II)
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2250
dockoike@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Niwa |
Organization
Nagoya University Hospital
Division name
Quality and Patient Safety
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2250
Homepage URL
yukiko-niwa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate 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
Address
Tel
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
| 2016 | Year | 02 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective single-institutional study, In patients fulfilling the criteria, QOL survey will carry out using EORTC-QLQ-C30/OES18. Survey is scheduled as follows; EORTC-QLQ-C30/OES18: preoperatively, on discharge, on postoperative 6,12,24-month.
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
