UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019024 |
|---|---|
| Receipt number | 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 | 2023/04/05 09:08:12 |
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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
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
siwama@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, School of Medicine
Institute
Department
Personal name
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
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
451
Results
Of the 451 patients, 51 developed thyroid irAEs after immunotherapy [41 of 416 (9.9%) treated with PD-1-Ab, 0 of 8 (0%) treated with CTLA-4-Ab, and 10 of 27 (37.0%) treated with PD-1/CTLA-4-Abs]. The cumulative incidence of thyroid irAEs was significantly higher in patients who were positive vs negative for ATAs at baseline after both PD-1-Ab [28/87 (32.2%) vs 13/329 (4.0%), P < 0.001] and PD-1/CTLA-4-Abs [6/10
(60.0%) vs 4/17 (23.5%), P < 0.05] treatments.
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
| 2026 | 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.
300 patients will be collected in each regimen for each malignancy.
Management information
Registered date
| 2015 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022004
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