UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021797 |
|---|---|
| Receipt number | R000025138 |
| Scientific Title | A Prospective Observational Study of Adoptive Immunotherapy for Cancer using Autologous Activated Lymphocytes |
| Date of disclosure of the study information | 2016/04/06 |
| Last modified on | 2023/04/13 13:10:22 |
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Basic information
Public title
A Prospective Observational Study of Adoptive Immunotherapy for Cancer using Autologous Activated Lymphocytes
Acronym
AIT
Scientific Title
A Prospective Observational Study of Adoptive Immunotherapy for Cancer using Autologous Activated Lymphocytes
Scientific Title:Acronym
AIT
Region
| Japan |
Condition
Condition
unresectable or recurrent cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Dermatology | Oto-rhino-laryngology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Overall Survival
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival
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
1) Histologically-defined panreatic cancer
2) Measurable lesion
3) un-treated
4) Age 20-80
5) PS 0-2
6) Estimated prognosis >= 3 months
7) Sufficient organ function
WBC>4,000/mm3, <12,000/mm3
NE>2,000/mm3
PLT>100.000/mm3
Hg>10.0g/dl
GOT/GPT<Normal range x 2
Bil<1.5mg/dl
Creat<1.5mg/dl
8) Written informed consent
9) No pregnancy
Key exclusion criteria
1) Autoimmune disease
2) Uncontrollable complications including
infection, diabetes, hypertension, ischemic heart disease, cerebral infarction, interstitial pneumonitis, cancer pain
3) Pregnancy
4) Allergy
5) General symptoms including dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, difficult for out-patient
6) Double cancer
7) Other cancer treatment
8) Steroid or immunosuppressive agents
9) Other unacceptable reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
701-0192
Address
Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
shogo@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | YAMAGUCHI |
| Middle name | |
| Last name | Yoshiyuki |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
701-0192
Address
Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
shogo@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
IRB for Regenerative Medicine of Kawasaki Medical School Hospital
Address
577 Matsushima Kurashiki
Tel
086-462-1111
hsyomu@med.kawasaki-m.ac.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 06 | 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
1000
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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A cohort study
Recruitment: All-comers who visit our department after April 2016, meet the inclusion criteria and do not conflict against exclusion criteria.
This treatment is approved as an advanced medicine until Mar 31st 2017.
Management information
Registered date
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025138
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
