UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039666
Receipt No. 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

* 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 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
Email 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
Email mnomura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Japan Science and Technology Agency
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045161

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.