UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009375 |
|---|---|
| Receipt number | 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 13:04:42 |
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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
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
Sponsor or person
Institute
Tokyo Clinic & Research Institute, ICVS Incorporated
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011021
