Anonymous Donors at Blood Donation Center (NUH) Clinical Trial
| NCT number | NCT01570439 |
| Other study ID # | KK001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | April 2, 2012 |
| Last updated | December 10, 2013 |
| Start date | January 2012 |
Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens
(URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.
Methods: The panel of candidate peptides are synthesized and tested for their ability to
induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable
for the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from
HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate
peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell
pulsed with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes
were negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for
their peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These
conditions are completely performed in in-vitro system. Importance in medicine: If one could
identify the peptide epitopes from novel Oncoantigens, it is applicable for clinical trials
of cancer vaccination.
Benefits & Risks : There is no risk except for the matter of venipuncture in each
individuals.
The ideal target molecules for cancer vaccination are thought to be selectively expressed in
tumor cells, but not in the normal cells, with high frequent and homogenous expression
within tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these
characters as ideal target molecules for the cancer vaccination and are highly expressed in
a variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101
haplotype is most frequent in Singaporean, it is essential to indentify the
HLA-A1101-restriced peptides derived from these Oncoantigens to develop cancer vaccination.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 22 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - The participants should be healthy, - non-pregnant adults who weigh at least 50kgs Exclusion Criteria: - Age of < 22 and > 80 years old. - Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) - Decision of unsuitableness by Principal Investigator or physician-in-charge. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Nationa University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National University Hospital, Singapore |
Singapore,
Kono K, Mizukami Y, Daigo Y, Takano A, Masuda K, Yoshida K, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Vaccination with multiple peptides derived from novel cancer-testis antigens can induce specific T-cell responses and clinical responses in advanced esophageal cancer. Cancer Sci. 2009 Aug;100(8):1502-9. doi: 10.1111/j.1349-7006.2009.01200.x. Epub 2009 May 14. — View Citation
Mizukami Y, Kono K, Daigo Y, Takano A, Tsunoda T, Kawaguchi Y, Nakamura Y, Fujii H. Detection of novel cancer-testis antigen-specific T-cell responses in TIL, regional lymph nodes, and PBL in patients with esophageal squamous cell carcinoma. Cancer Sci. 2008 Jul;99(7):1448-54. doi: 10.1111/j.1349-7006.2008.00844.x. Epub 2008 Apr 30. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore. |