UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053154 |
|---|---|
| Receipt number | R000058961 |
| Scientific Title | Exploratory analysis of gut microbiome as a novel biomarker in patients with advanced thymic carcinoma on immunochemotherapy |
| Date of disclosure of the study information | 2023/12/19 |
| Last modified on | 2023/12/19 12:58:14 |
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Basic information
Public title
Exploratory analysis of gut microbiome as a novel biomarker in patients with advanced thymic carcinoma on immunochemotherapy
Acronym
NCCH2109A
Scientific Title
Exploratory analysis of gut microbiome as a novel biomarker in patients with advanced thymic carcinoma on immunochemotherapy
Scientific Title:Acronym
NCCH2109A
Region
| Japan |
Condition
Condition
thymic carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore biomarkers useful in predicting the outcome of treatment with carboplatin + paclitaxel + pembrolizumab + lenvatinib for untreated unresectable thymic carcinoma.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the composition of the intestinal flora is a predictive factor
Key secondary outcomes
Whether plasma biomarkers are predictive factors
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
Written consent to participate in this accessory study has been obtained prior to the start of protocol treatment in the main study (NCCH2109).
Key exclusion criteria
none
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuma |
Organization
National Cancer Center Hospital
Division name
Department of thoracic oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
ncch2109_jimukyoku@is-pc.or.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuma |
Organization
National Cancer Center Hospital
Division name
Department of thoracic oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
ncch2109_jimukyoku@is-pc.or.jp
Sponsor or person
Institute
Yusuke Okuma, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
pending
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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
| 2023 | Year | 12 | Month | 19 | 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
| 2023 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058961
