UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041822
Receipt No. R000047745
Scientific Title Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Date of disclosure of the study information 2020/10/01
Last modified on 2021/01/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Acronym Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Scientific Title Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Scientific Title:Acronym Prospective study analyzed the association between efficacy and adverse events by Atezolizumab immunotherapy and diversity or species of fecal microbiota in advanced /reccurent non-small cell lung cancer patients
Region
Japan

Condition
Condition advanced/reccurent non-small cell lung cancer patients
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the relationship of the response and adverse events of combined- or mono-therapy using Atezolizumab, and the diverstiy or sepcific species of fecal microbiota in non-small cell lung cancer patiennts.
Basic objectives2 Others
Basic objectives -Others To analyze the correlation of fecal microbiota profiles and clinico-pathological features, prognosis and immune-related adverse events cased by Atezolizumab immunetherapy.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Relapse-free 6 months survival according to the diversity and specific species of fecal microbiota.
Overall 12 months survival according to the diversity and specific species of fecal microbiota.
The incident rates of immune-related adverse events (>= Grade3) according to the diversity and specific species of fecal microbiota.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) pathologically or cytologically confirmed non-small cell lung cancer
(2) >= 2o years at the time of informed consent
(3) Planned to treat with Atezolizumab combined chemotheapy or Atezolizumab monotherapy
(4) Informed consent obtained from patients
(5) Cases that feces can be collected
Key exclusion criteria (1) Inadequate cases judged by doctors
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Fumihiro
Middle name
Last name Shoji
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Thoracic Surgery
Zip code 810-8563
Address 1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL 092-852-0700
Email fshoji@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Fumihiro
Middle name
Last name Shoji
Organization National Hospital Organization Kyushu Medical Center
Division name Department of Thoracic Surgery
Zip code 810-8563
Address 1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL 092-852-0700
Homepage URL
Email fshoji@surg2.med.kyushu-u.ac.jp

Sponsor
Institute National Hospital Organization Kyushu Medical Center, Clinical Research Institute
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Kyushu Medical Center
Address 1-8-1, Jigyohama, Chuo-ku, Fukuoka
Tel 092-852-0700
Email fshoji@surg2.med.kyushu-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
2020 Year 10 Month 01 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
2020 Year 08 Month 06 Day
Date of IRB
2020 Year 09 Month 23 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1) Relapse-free 6 months survival according to the diversity and specific species of fecal microbiota
(2) Overaall 12 months survival according to the diversity and specific species of fecal microbiota
(3) Incident rate of Grade 3 or more immune-related adverse events according to the diversity and specific species of fecal microbiota

Management information
Registered date
2020 Year 09 Month 17 Day
Last modified on
2021 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047745

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.