UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044137 |
|---|---|
| Receipt number | R000050397 |
| Scientific Title | Prospective observational study on gut microbiome as a novel biomarker for patients with cancer cachexia treated with anamorelin |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2022/05/18 10:05:05 |
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Basic information
Public title
Prospective observational study on gut microbiome as a novel biomarker for patients with cancer cachexia treated with anamorelin
Acronym
Exploratory analysis of gut microbiome in patients with cancer cachexia
Scientific Title
Prospective observational study on gut microbiome as a novel biomarker for patients with cancer cachexia treated with anamorelin
Scientific Title:Acronym
Exploratory analysis of gut microbiome in patients with cancer cachexia
Region
| Japan |
Condition
Condition
Cancer cachexia
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the efficacy and safety of anamorelin in clinical practice, as well as the utility of gut microbiome as a biomarker for cancer cachexia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the composition of gut microbiome 3 weeks after the start of anamorelin
Key secondary outcomes
1. Association between the composition of gut microbiome at the start of anamorelin and its clinical effects
2. Clinical effects 3, 6 and 12 weeks after the start of anamorelin administration
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Unresectable advanced/recurrent non-small cell lung cancer, gastric cancer, pancreatic cancer, or colorectal cancer.
2. Subjects who is going to receive anamorelin in clinical practice for cancer cachexia (Cohort A). As a control, patients without cancer cachexia and patients with cancer cachexia who do not receive anamorelin are also included (Cohort B).
3. 20 years of age or older.
4. Signed informed consent form.
Key exclusion criteria
1. Subjects who could not give their consent.
2. Subjects with illnesses or conditions that interfere with their capacity to understand, follow and/or comply with study procedures.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hosomi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-0021
Address
3-18-22, Honkomagome, Bunkyo-Ku, Tokyo
TEL
03-3823-2101
yhosomi@cick.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Hakozaki |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-0021
Address
3-18-22, Honkomagome, Bunkyo-Ku, Tokyo
TEL
03-3823-2101
Homepage URL
t-hakozaki@akane.waseda.jp
Sponsor or person
Institute
Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Ethics Review Board
Address
3-18-22, Honkomagome, Bunkyo-Ku, Tokyo
Tel
03-3823-2101
rinri@cick.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
| 2021 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050397
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
