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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042487
Receipt No. 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 2020/11/17

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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
Email 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
Email takoyama@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Email 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
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 11 Month 17 Day
Last modified on
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048498

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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