UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042487 |
|---|---|
| Receipt number | R000048498 |
| Scientific Title | Retrospective Study of Safety and Efficacy in Phase I Oncology Trials |
| Date of disclosure of the study information | 2020/11/18 |
| Last modified on | 2025/05/24 09:43:29 |
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Basic information
Public title
Retrospective Study of Safety and Efficacy
in Phase I Oncology Trials
Acronym
Retrospective Study of Safety and Efficacy
in Phase I Oncology Trials
Scientific Title
Retrospective Study of Safety and Efficacy
in Phase I Oncology Trials
Scientific Title:Acronym
Retrospective Study of Safety and Efficacy
in Phase I Oncology Trials
Region
| Japan |
Condition
Condition
Advanced cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore the factors determining the safety and efficacy for patients who were considered for or participated in phase I clinical trials in our hospital, by capturing the clinical background, treatment effects, adverse events, and etc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anti-tumor effect
Key secondary outcomes
Age, Performance Status, cancer type, genetic variants, stage, comorbidities, Investigational drug, serious adverse event, progression-free survival, date of study entry, start date, date of withdrawal, date of treatment end, date of death, or final follow-up date, and etc.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We define patients who were considered or participated in phase I clinical trials between January 1, 1995, and September 30, 2024, at the National Cancer Center Hospital.
Key exclusion criteria
Nothing specific
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, 104-0045, Tokyo, Japan
TEL
03-3542-2511
nbryamam@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, 104-0045, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
takoyama@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
Tsukiji 5-1-1, Chuo-ku, 104-0045, Tokyo, Japan
Tel
03-3542-2511
NCCH1616_office@ml.res.ncc.go.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
国立がん研究センター中央病院（東京）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048498
