UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028523
Receipt number R000032643
Scientific Title Identification of genetic markers that predicts adverse effects of new melanoma therapies
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/06 08:36:30

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Basic information

Public title

Identification of genetic markers that predicts adverse effects of new melanoma therapies

Acronym

Identification of genetic markers that predicts adverse effects of new melanoma therapies

Scientific Title

Identification of genetic markers that predicts adverse effects of new melanoma therapies

Scientific Title:Acronym

Identification of genetic markers that predicts adverse effects of new melanoma therapies

Region

Japan


Condition

Condition

malignant melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To identify HLA and KIR alleles that correlate with adverse effect of melanoma new therapy

Basic objectives2

Others

Basic objectives -Others

Pharmacogenetics

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse effect that result from new melanoma therapy

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

Patients who are treated with systemic therapies

Key exclusion criteria

Patients who are followed for less than 3 months after the initiation of the therapy

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Otsuka

Organization

Kyoto University

Division name

Dermatology

Zip code

606-8507

Address

54 Kawahara-cho Shogoin Sakyo-ku Kyoto-shi 606-8507 Japan

TEL

075-751-3310

Email

otsukamn@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Chisa
Middle name
Last name Nakashima

Organization

Kyoto University

Division name

Dermatology

Zip code

606-8507

Address

54 Kawahara-cho Shogoin Sakyo-ku Kyoto-shi 606-8507 Japan

TEL

075-751-33310

Homepage URL


Email

chisa313@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb K.K.

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

Kyoto University

Address

54 Kawahara-cho Shogoin Sakyo-ku Kyoto-shi

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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

112

Results

Our analysis showed that no KIR gene was associated with a response to nivolumab. The KIR/KIR-ligand combination did not correlate with a response to nivolumab. KIR genes were not predictive of experiencing adverse events of grade 2 or greater. We conclude that the KIR genotype or KIR/KIR-ligand genotype do not show predictive value in melanoma patients receiving nivolumab.

Results date posted

2019 Year 08 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

none

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 01 Day

Date of IRB

2017 Year 10 Month 23 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2018 Year 12 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To identify HLA alleles that correlate with adverse effect of new melanoma therapy


Management information

Registered date

2017 Year 08 Month 03 Day

Last modified on

2019 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032643


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name