臨床研究等提出・公開システム

Date of registration	Jan. 23, 2022
Last modified on	Jan. 23, 2022
Trial ID	jRCT1071210120

Scientific Title	An ancillary study of 'Investigation of efficacy of nivolumab in patients with recurrent and refractory peripheral T cell lymphoma: Investigator initiated phase 2 clinical trial' (W-JHS NHL02-A)
Public Title	W-JHS NHL02-A study (W-JHS NHL02-A)

Contact for Scientific Queries	Name	Akashi Koichi
	Affiliation	Kyushu University Graduate School of Medical Science
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan
	Telephone	+81-92-642-5230
	E-mail	akashi@med.kyushu-u.ac.jp
Contact for Public Queries	Name	Koji Kato
	Affiliation	Kyushu University Hospital
	Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan
	Telephone	+81-92-642-5230
	E-mail	kato.koji.429@m.kyushu-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2018
Actual date of first enrollment		April. 25, 2019
Target sample size		20
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients enrolled in W-JHS NHL02 study (jRCT2071210101) 2) Patients providing the written informed consent. 3) Patients whose specimens for any test in 'biomarker exploration' can be submitted
	Exclusion Criteria	Nothing particular
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Peripheral T-cell lymphoma (including extranodal NK/T-cell lymphoma)
Primary Outcome(s)		Gene and protein expression, gene mutation, lymphocyte subset analysis, serum cytokine and chemokine, HLA gene, single cell analysis
Secondary Outcome(s)		Nothing

Primary Sponsor	Kyushu University Hospital

Source of Monetary Support / Secondary Sponsor	Ono Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Secondary Sponsor

Name of Certified Review Board	NPO Clinical Research Network Fukuoka Ethics Committee
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka-city, Fukuoka 812-8582, Japan, Fukuoka
Telephone	+81-92-643-7171
E-Mail	mail@crnfukuoka.jp
Approval Status	Approval
Date of approval	Sept. 20, 2018

Plan to share IPD	No

Secondary ID(s)	UMIN000034502
Issuing Authority	University hospital Medical Information Network (UMIN)

Countries of Recruitment（Except Japan）	none