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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044137
Receipt No. 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 2021/05/21

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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.
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
Email 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
Email t-hakozaki@cick.jp

Sponsor
Institute Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

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
Email 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
2021 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050397

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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