UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000028523 |
| Receipt No. | 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 (Ver. 11) |
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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 | |
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| Condition | ||
| Condition | malignant melanoma | |
| Classification by specialty |
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| 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 | |
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| Purpose of intervention | |
| Type of intervention | |
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| Eligibility | ||||
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| 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 | |||
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| Name of lead principal investigator |
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| 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 | ||||||
| otsukamn@kuhp.kyoto-u.ac.jp | |||||||
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| Name of contact person |
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| 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 | |||||||
| chisa313@kuhp.kyoto-u.ac.jp | |||||||
| Sponsor | |
| Institute | Kyoto University |
| Institute | |
| Department | |
| 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 |
| 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 | |
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| Date of disclosure of the study information |
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| 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. |
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| Baseline Characteristics | |||||||
| Participant flow | |||||||
| Adverse events | none |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | To identify HLA alleles that correlate with adverse effect of new melanoma therapy |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032643 |
