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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009375
Receipt No. R000011021
Scientific Title Routine follow-up based on RECIST guidelines on patients with recurrence and stage IV cancer undergoing a combination of immunotherapy using immature dendritic cells (iDC) and conventional therapies.
Date of disclosure of the study information 2012/11/21
Last modified on 2012/11/21

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Basic information
Public title Routine follow-up based on RECIST guidelines on patients with recurrence and stage IV cancer undergoing a combination of immunotherapy using immature dendritic cells (iDC) and conventional therapies.
Acronym Routine follow-up on patients with recurrence and stage-IV cancer undergoing a combination of immunotherapy and conventional therapies.
Scientific Title Routine follow-up based on RECIST guidelines on patients with recurrence and stage IV cancer undergoing a combination of immunotherapy using immature dendritic cells (iDC) and conventional therapies.
Scientific Title:Acronym Routine follow-up on patients with recurrence and stage-IV cancer undergoing a combination of immunotherapy and conventional therapies.
Region
Japan Asia(except Japan)

Condition
Condition Stage-IV and recurrence cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Dermatology Oto-rhino-laryngology
Urology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To follow-up cancer patients with recurrence and stage-IV undergoing a combination of immunotherapy and conventional therapies using RECIST guidelines.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation using RECIST 6 weeks after a course, then every 3 months during the first year, every 6 months in the 2nd year, and once a year after the 3rd year.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Cancer patients with recurrence and stage-IV who have solid tumors
Key exclusion criteria Blood cancer patients
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichiro HASUMI
Organization Tokyo Clinic & Research Institute, ICVS Incorporated
Division name Oncology Department
Zip code
Address Shin-kioicho Bldg. 4F, 4-1 Kioi-cho, Chiyoda-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Clinic & Research Institute, ICVS Incorporated
Division name Oncology Department
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Clinic & Research Institute, ICVS Incorporated
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hasumi International Research Foundation. University of Maryland School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 11 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2005 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case report, Case series studies

Management information
Registered date
2012 Year 11 Month 21 Day
Last modified on
2012 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011021

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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