UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054367 |
|---|---|
| Receipt number | R000061821 |
| Scientific Title | Clinical impact of intestinal flora and nutritional status after esophagectomy |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2024/11/09 10:05:24 |
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Basic information
Public title
Clinical impact of intestinal flora and nutritional status after esophagectomy
Acronym
Clinical impact of intestinal flora and nutritional status after esophagectomy
Scientific Title
Clinical impact of intestinal flora and nutritional status after esophagectomy
Scientific Title:Acronym
Clinical impact of intestinal flora and nutritional status after esophagectomy
Region
| Japan |
Condition
Condition
Thoracic esophageal squamous cell carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the clinical impact of intestinal flora and postoperative nutritional status after esophagectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal flora and body weight loss at 1 month postoperatively
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pt. over 17 years old at registration.
Histologically proven esophageal squamous cell carcinoma.
Pt. underwent esophagectomy.
Pt. with ECOG-Performance status 0-2.
Written informed consent.
Key exclusion criteria
Under treatment with immunosuppressant or steroid.
Pt. with synchronous or metachronous (within 5 years) malignancies.
Having a psychological disorder that makes it difficult to participate in this clinical study.
No informed consent is obtained.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasufumi |
| Middle name | |
| Last name | Koterazawa |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-5925
kote1128@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasufumi |
| Middle name | |
| Last name | Koterazawa |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Surgery
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-5925
Homepage URL
kote1128@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Taisho pharmaceutical holdings
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
Clinical and translational research center
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City
Tel
078-382-6669
kansatsu@med.kobe-u.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
| 2024 | Year | 05 | Month | 10 | 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
| 2024 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061821
