Development of activated natural killer (NK) cells mediated immunotherapy in cancer

ISRCTN ISRCTN79498301
DOI https://doi.org/10.1186/ISRCTN79498301
Secondary identifying numbers N/A
Submission date
15/07/2008
Registration date
08/08/2008
Last edited
16/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Hareum Lee
Scientific

Department of Life Sciences
Sookmyung Women's University
Hyochangwon-gil 52
Yongsan-gu
Seoul
140-742
Korea, South

Study information

Study designSingle-centre, observational study
Primary study designObservational
Secondary study designOther
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleResearch for the effect of biological response modifiers (BRMs) on natural killer (NK) cell cytotoxicity
Study objectivesNatural killer (NK) cells play an important role in innate immune response by destroying tumours and virus-infected cells without prior stimulation. Because of their attractive features, the application of NK cell-based immunotherapy has been extended to cancer treatment. This study investigates the function of biological response modifiers (BRMs) on NK cell cytotoxicity and the effect of NK cell mediated immunotherapy in cancer.
Ethics approval(s)Samsung Medical Centre Institutional Review Board. Date of approval: 18/03/2008 (ref: 2008-03-038)
Health condition(s) or problem(s) studiedImmunotherapy in cancer
InterventionA blood sample will be obtained from each participant. A variety of BRMs (small synthetic peptides, interleukins, natural extracts) will be tested on the blood samples to measure their effect on NK cell cytotoxicity. This will be measured using established assays such as carboxyfluorescein diacetate succinimidylester (CFSE). The BRMs that show high levels of NK cell cytotoxicity will have the potential for use in cancer treatment.

Contact details of Principal Investigator:
Dr Daeho Cho
Department of Life Sciences
Sookmyung Women's University
Hyochangwon-gil 52
Yongsan-gu
Seoul, 140-742
Korea, South
Tel: +82 2 710 9416
Fax: +82 2 6359 6789
Email: cdhkor@sm.ac.kr
Intervention typeOther
Primary outcome measure1. To find BRMs that lead to the highest levels of NK cell cytotoxicity in the treated blood samples
2. To find the optimum dose and duration of treatment with the BRMs found to elicit highest levels of NK cell cytotoxicity
Secondary outcome measuresGene expression profiles associated with peripheral blood lymphocyte (PBL) cytotoxicity and related mechanisms in the blood samples.
Overall study start date01/05/2008
Completion date30/04/2010

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. Healthy volunteers aged 18 years or older, both males and females
2. Written informed consent
Key exclusion criteria1. Aged less than 18 years
2. Those who do not speak Korean
Date of first enrolment01/05/2008
Date of final enrolment30/04/2010

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Department of Life Sciences
Seoul
140-742
Korea, South

Sponsor information

Sookmyung Women's University (Korea, South)
University/education

Hyochangwon-gil 52
Yongsan-gu
Seoul
140-742
Korea, South

Website http://www.sookmyung.ac.kr
ROR logo "ROR" https://ror.org/00vvvt117

Funders

Funder type

Government

Korea Health Industry Development Institute (KHIDI) (ref: A080363)
Government organisation / National government
Alternative name(s)
KHIDI
Location
Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan