UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Project for Risk Identification of Immune-Mediated Adverse Events
Title of the study (Brief title)	PRIME study
Region	Japan

Condition
Condition	Malignant Neoplasm
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To identify the mechanism and risk factors for immune-mediated adverse events(im AEs) in cancer patients received immune checkpoint inhibitors, the blood samples are analyzed. The primary aim is the identification of autoantibodies associated with imAEs and genetic characteristics of cases with imAE.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of specific autoantibodies
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	Cance patients treated with immune checkpoint inhibitors (nivolumab, ipilimumab, pembrolizumab, avelumab, atezolizumab).
Key exclusion criteria	Patients with any condition, in the opinion of the investigator, have the limitation of ability to comply with the study requirements or impact the interpretability of study results.
Target sample size	300

Research contact person
Name of lead principal investigator	Shunichiro Iwasawa
Organization	Department of Respirology, Graduate School of Medicine, Chiba University
Division name	Department of advancing research on treatment strategies for respiratory disease (DARTS)
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email	iwasawas@chiba-u.jp

Public contact
Name of contact person	Shunichiro Iwasawa
Organization	Department of Respirology, Graduate School of Medicine, Chiba University
Division name	Department of advancing research on treatment strategies for respiratory disease (DARTS)
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Homepage URL
Email	iwasawas@chiba-u.jp

Sponsor
Institute	Department of Respirology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 23 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2018 Year 06 Month 29 Day
Last modified on	2018 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037849