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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021797
Receipt No. 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 2017/04/06

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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 Obsterics 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
Middle name
Last name Yoshiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Email shogo@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki YAMAGUCHI
Organization Kawasaki Medical School
Division name Department of Clinical Oncology
Zip code
Address Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email shogo@med.kawasaki-m.ac.jp

Sponsor
Institute Others
Institute
Department

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
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
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
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
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 06 Day
Last follow-up date
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
2017 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.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


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