UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004610 |
|---|---|
| Receipt number | R000005503 |
| Scientific Title | Clinical prospective study to investigate efficacy and safety of immune-cell therapy for malignant tumors |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/08/06 10:00:45 |
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Basic information
Public title
Clinical prospective study to investigate efficacy and safety of immune-cell therapy for malignant tumors
Acronym
Prospective Study of immune-cell therapy for malignant tumors
Scientific Title
Clinical prospective study to investigate efficacy and safety of immune-cell therapy for malignant tumors
Scientific Title:Acronym
Prospective Study of immune-cell therapy for malignant tumors
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Nephrology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Urology | Oral surgery |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of immune-cell therapy for Malignant tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression free survival
Relapse free survival
Antitumor effect
Quality of life
Severe Adverse Event (SAE)
Immunological response
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 patient:
1) Diagnostic imaging or Pathological diagnosis f malignant cancer
2)Performance Status is 0-2
3)No serious abnormality in heart, lung, bone marrow, liver, and renal functions
4) Informed consent has been obtained
Key exclusion criteria
Patients who have:
1) T cell, NK cell lymphoma and leukemia
2) HTLV-I Ab and/or HIV Ab positive (LAK therapy), HIV Ab positive (DC therapy)
3) interstitial pneumonia, including their history or predisposition of them,
4) Active autoimmune diseases
5) Active cardiac disease
6) Serious drug allergy
7) Pregnancy woman, or woman with suspected pregnancy, lactating woman
8) Responsible doctors judged the patient inappropriate for the clinical study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa university
Division name
Graduate school of medicine
Zip code
Address
Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2233
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuro Tomita |
Organization
Kanazawa advanced medical center (KadMedic)
Division name
Personalized medicine center
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa, 920-0934, JAPAN
TEL
076-255-3413
Homepage URL
meneki@kadmedic.jp
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
Funding Source
Organization
no
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
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
金沢先進医学センター（石川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate efficacy and safety of immune-cell therapy for Malignant tumor
Management information
Registered date
| 2010 | Year | 11 | Month | 23 | Day |
Last modified on
| 2015 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005503
