Condition category
Cancer
Date applied
15/07/2008
Date assigned
08/08/2008
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Hareum Lee

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Research for the effect of biological response modifiers (BRMs) on natural killer (NK) cell cytotoxicity

Acronym

Study hypothesis

Natural 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

Samsung Medical Centre Institutional Review Board. Date of approval: 18/03/2008 (ref: 2008-03-038)

Study design

Single-centre, observational study

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Immunotherapy in cancer

Intervention

A 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. 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 measures

Gene expression profiles associated with peripheral blood lymphocyte (PBL) cytotoxicity and related mechanisms in the blood samples.

Overall trial start date

01/05/2008

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers aged 18 years or older, both males and females
2. Written informed consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Aged less than 18 years
2. Those who do not speak Korean

Recruitment start date

01/05/2008

Recruitment end date

30/04/2010

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Life Sciences
Seoul
140-742
Korea, South

Sponsor information

Organisation

Sookmyung Women's University (Korea, South)

Sponsor details

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

Sponsor type

University/education

Website

http://www.sookmyung.ac.kr

Funders

Funder type

Government

Funder name

Korea Health Industry Development Institute (KHIDI) (ref: A080363)

Alternative name(s)

KHIDI

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes