Anonymous Donors at Blood Donation Center (NUH)NCT01570439
To Identify HLA-A1101-restricted Peptide Epitopes Derived From Novel Oncoantigens (URLC10, KIF20A, and CDCA1) Applicable for Cancer Vaccine in Singapore
An observational study of Anonymous Donors at Blood Donation Center (NUH), run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anonymous Donors at Blood Donation Center (NUH)
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anonymous donors at blood donation center in NUH.
Who may be able to join
- The participants should be healthy,
- non-pregnant adults who weigh at least 50kgs
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Nationa University Hospital
Singapore
Wei Peng Yong, MRCP, +65 6779 5555, Wei_Peng_Yong@nuhs.edu.sg
Wei Peng Yong, MRCP
About this study
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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anonymous Donors at Blood Donation Center (NUH)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570439
- Sponsor's protocol ID
- KK001
- Status last verified
- Dec 2013
- First submitted
- 2 Apr 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19459850Mizukami 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.
PubMed 18452554
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Identify HLA-A1101-restricted Peptide Epitopes Derived From Novel Oncoantigens (URLC10, KIF20A, and CDCA1) Applicable for Cancer Vaccine in Singapore
- ClinicalTrials.gov ID
- NCT01570439
- Acronym / sponsor ID
- KK001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anonymous donors at blood donation center in NUH.
Key inclusion criteria (2 listed)
- The participants should be healthy,
- non-pregnant adults who weigh at least 50kgs
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Background: PubMed 19459850Kono 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.
- Background: PubMed 18452554Mizukami 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anonymous Donors at Blood Donation Center (NUH), run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Peng Yong, MRCP (+65 6779 5555, Wei_Peng_Yong@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570439, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.