UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039666 |
|---|---|
| Receipt number | R000045161 |
| Scientific Title | Biomarker Study for Combined nivolumab and ipilimumab in Fecal microbiota metabolites of Advanced malignant melanoma |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/03/11 17:43:35 |
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Basic information
Public title
Biomarker Study for Combined nivolumab and ipilimumab in Fecal microbiota metabolites of Advanced malignant melanoma
Acronym
SCFA study
Scientific Title
Biomarker Study for Combined nivolumab and ipilimumab in Fecal microbiota metabolites of Advanced malignant melanoma
Scientific Title:Acronym
SCFA study
Region
| Japan |
Condition
Condition
Malignant melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the therapeutic effect/toxicity of combined nivolumab and ipilimumab in patients with unresectable malignant melanoma and the fecal microbiota metabolites.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between the quantity and type of fecal microbiota metabolites before and after the treatment and the prognosis and tumor reduction effect.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
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) Histologically diagnosed as malignant melanoma.
2) Clinically and imagingly diagnosed as unresectable malignant melanoma. However, choroidal melanoma is excluded.
3) Over 20 years old.
4) Nivolumab + ipilimumab combination therapy is planned for future treatment.
5) Having a measurable lesion.
6) No prior treatment with ipilimumab.
7) The patient has given written consent to participate in the study.
Key exclusion criteria
Patients who are considered inappropriate for the investigator to participate in the study are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigemi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University Hospital
Division name
Therapeutic oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan.
TEL
075-751-4592
motocame@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoo |
| Middle name | |
| Last name | Nomura |
Organization
Kyoto University Hospital
Division name
Therapeutic oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto, Japan.
TEL
075-751-3518
Homepage URL
mnomura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
Tel
075-753-4680
ethcom@kuhp.kyoto-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
旭川医科大学病院(北海道)
札幌医科大学附属病院(北海道)
信州大学医学部附属病院(長野県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学国際医療センター(埼玉県)
がん・感染症センター 東京都立駒込病院(東京都)
東京大学医学部附属病院(東京都)
国立がん研究センター中央病院(東京都)
名古屋大学医学部附属病院(愛知県)
静岡県立 静岡がんセンター(静岡県)
大阪国際がんセンター(大阪府)
福岡大学病院(福岡県)
熊本大学病院(熊本県)
鹿児島医療センター(鹿児島県)
立命館大学 薬学部 臨床分析化学研究室(滋賀県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood and stool collection are performed twice before treatment and during the 22nd to 43th days after the start of treatment.
Management information
Registered date
| 2020 | Year | 03 | Month | 02 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045161
| Research Plan | |
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| 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 |
