UMIN-CTR Clinical Trial

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
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@akane.waseda.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	2022 Year 05 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050397