UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001016
Receipt No. R000001228
Scientific Title Trial for in vitro screening of cytotoxic T lymphocyte induction with use of allogeneic dendritic cells for patients with pleural or peritoneal carcinomatosis
Date of disclosure of the study information 2008/02/05
Last modified on 2009/11/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Trial for in vitro screening of cytotoxic T lymphocyte induction with use of allogeneic dendritic cells for patients with pleural or peritoneal carcinomatosis
Acronym In vitro screening of CTL induction by allogeneic dendritic cells for pleural or peritoneal carcinomatosis
Scientific Title Trial for in vitro screening of cytotoxic T lymphocyte induction with use of allogeneic dendritic cells for patients with pleural or peritoneal carcinomatosis
Scientific Title:Acronym In vitro screening of CTL induction by allogeneic dendritic cells for pleural or peritoneal carcinomatosis
Region
Japan

Condition
Condition Peritoneal or pleural carcinomatosis (carcinomas of the stomach, colorectum, biliary duct, pancreas, uterus, ovary, kidney, lung or malignant melanoma etc.) and malignant mesothelioma
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
Chest surgery Obsterics and gynecology Dermatology
Urology Blood transfusion
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Cancer-specific cytotoxic T lymphocyte (CTL) induction rate by dendritic cells is evaluated for the patients with peritoneal or pleural carcinomatosis in vitro.
Basic objectives2 Others
Basic objectives -Others Cytotoxic activity or cytokine production is evaluated for the CTL induced by auto dendritic cells compared with that induced by allogeneic DCs.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Induction rate of cancer-specific cytotoxic T lymphocyte (CTL) in vitro
Key secondary outcomes Cytotoxic potency or cytokine production of the cancer-specific CTL

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) Patients who have been already clinically or histologically diagnosed as primary or recurrent stomach, colorectal, biliary, pancreas, uterine, ovarian, renal, lung cancers or malignant melanoma etc, or malignant mesothelioma with pleural or peritoneal carcinomatosis.
2) Malignant cells (class V) are detected in ascites or pleural effusion by cytological test. 3) New chemotherapy or radiotherapy should not be started during the present study.
4) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6) Body weight is more than 45kg for male and 40kg for female.
7) Expected survival over 6 months.
8) Written informed consent must be obtained from patients and legally acceptable representatives.
Key exclusion criteria 1) Active double cancer.
2) Exclude the patients who have serious illness or suspect to have serious illness.
3) Myocardial infarction or unstable angina, occurred within 6 months.
4) Psychosis.
5) Women during pregnancy or breast-feeding.
6) Previous history of severe drug-induced allergy.
7) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kamigaki
Organization Kobe University Graduate School of Medicine
Division name Division of Gastrointestinal Surgery
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL 078-382-5925
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kamigaki
Organization Kobe University Hospital
Division name Division of Gastrointestinal Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe city, Hyogo
TEL 078-382-5925
Homepage URL http://www.med.kobe-u.ac.jp/surg1/index.html
Email menekidc@med.kobe-u.ac.jp

Sponsor
Institute Division of Gastrointestinal Surgery, Kobe University Hospital
Institute
Department

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

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
2008 Year 02 Month 05 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 No longer recruiting
Date of protocol fixation
2007 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Superiority of allogeneic dendritic cells for induction of the CTL to auto dendritic cells.

Management information
Registered date
2008 Year 02 Month 05 Day
Last modified on
2009 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.