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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019024
Receipt No. R000022004
Scientific Title Research for endocrinological disorders associated with immune checkpoint inhibitors
Date of disclosure of the study information 2015/12/01
Last modified on 2020/06/15

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Basic information
Public title Research for endocrinological disorders associated with immune checkpoint inhibitors
Acronym Immune checkpoint inhibitors & endocrine adverse effects
Scientific Title Research for endocrinological disorders associated with immune checkpoint inhibitors
Scientific Title:Acronym Immune checkpoint inhibitors & endocrine adverse effects
Region
Japan

Condition
Condition Cancer patients treated with immune checkpoint inhibitors
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify clinical features in patients with endocrine disorders associated with immune checkpoint inhibitors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Development of endocrine adverse events after treatment with immune checkpoint inhibitors
Key secondary outcomes Changes in pituitary, thyroid, and diabetes hormones as well as the presence of anti-pituitary antibodies
Findings of pituitary MRI

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cancer patients treated with immune checkpoint inhibitors
Key exclusion criteria Cancer patients not treated with immune checkpoint inhibitors
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Arima
Organization Nagoya University
Division name Department of Endocrinology and Diabetes
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL +81-52-744-2142
Email arima105@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Shintaro
Middle name
Last name Iwama
Organization Nagoya University Hospital
Division name Department of Endocrinology and Diabetes
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
TEL +81-52-744-2142
Homepage URL
Email siwama@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University, School of Medicine
Institute
Department

Funding Source
Organization A part of this research is funded by Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. as an academia initiated sponsored research in Nagoya University.
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 IRB, Nagoya University, School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan
Tel 052-744-2479
Email iga-shinsa@adm.nagoya-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
2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://www.nature.com/articles/s41416-020-0736-7
Number of participants that the trial has enrolled 209
Results
Of the 209 patients, 19 (9.1%) developed thyroid dysfunction. The cumulative incidence of thyroid dysfunction was significantly higher in patients who were positive vs. negative for anti-thyroid antibodies (15/44 vs. 4/165). The cumulative incidence of thyroid dysfunction was significantly higher in those with an irregular vs. a regular echo pattern (56.5% vs. 5.3%).
Results date posted
2020 Year 06 Month 15 Day
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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 14 Day
Date of IRB
2015 Year 11 Month 02 Day
Anticipated trial start date
2015 Year 11 Month 10 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The development of endocrinological disorders is monitored.
Study design; prospective study
Eligibility criteria; All subjects who show the informed consent and meet the eligibility criteria of the study since Nov. 2, 2015 will be included.
Monitored tests; Before and after administration of the immune checkpoint inhibitors, pituitary hormones, thyroid hormone, thyroid autoantibodies, thyroid ultrasonography adrenal hormone and parameters associated with diabetes are tested. Pituitary MRI is tested after treatment.
Data analysis;
Association of anti-thyroid antibodies (Thyroglobulin antibodies, TPO antibodies) with the development of thyroid dysfunction.
Association of anti-thyroid antibodies (Thyroglobulin antibodies, TPO antibodies) with the anti-tumor effects (overall survival, progression free survival, response rate).
Association of the findings of thyroid ultrasonography with the development of thyroid dysfunction.
Association of endocrine irAEs or all irAEs with the anti-tumor effects (overall survival, progression free survival, response rate).
Analyzed data will be published before we recruit 100 subjects, if they are clinically important.
We analyze the clinical practice data for up to 5 years to clarify the characteristics of irAEs and the association of irAEs with the anti-tumor effects.

Management information
Registered date
2015 Year 09 Month 15 Day
Last modified on
2020 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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