Gastric CancerNCT02078362
ADCC Against Gastric Cancer Cells
An observational study of Gastric Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Peripheral blood will be taken from the enrolled patients at National University Hospital and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine candidates. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2013to May 2018
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer patients treated at National University Hospital.
Who may be able to join
- For the gastric cancer patients, patients with 21 years of age and above and younger than 80 years old who have gastric cancer can enroll in this study. For the healthy donors, healthy volunteers with 21 years of age and above and younger than 80 years old can enroll in this study.
Who cannot join
- Age of <21 and >80 years old (B) Pregnancy (C) Decision of unsuitableness by Principal Investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Wei Peng Yong, MRCP, +65 6779 5555, wei_peng_yong@nuhs.edu.sg
Wei Peng Yong, MRCP
About this study
Official title: Evaluation of Antibody-dependent Cell Cytotoxicity (ADCC) Against Gastric Cancer Cells
Peripheral blood will be taken from the enrolled patients at National University Hospital and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine candidates.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cell lysis
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2016 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haematology-Oncology, National University Hospital, Singapore
- Investigators
- Wei Peng Yong, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078362
- Sponsor's protocol ID
- KK002
- Other IDs
- 2013/00654
- Status last verified
- Jun 2015
- First submitted
- 9 Dec 2013
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.
PubMed 11547741
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibody-dependent Cell Cytotoxicity (ADCC) Against Gastric Cancer Cells
- ClinicalTrials.gov ID
- NCT02078362
- Acronym / sponsor ID
- KK002
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 5 Mar 2014 (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.
Peripheral blood will be taken from the enrolled patients at National University Hospital and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine candidates.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer patients treated at National University Hospital.
Key inclusion criteria (1 listed)
- For the gastric cancer patients, patients with 21 years of age and above and younger than 80 years old who have gastric cancer can enroll in this study. For the healthy donors, healthy volunteers with 21 years of age and above and younger than 80 years old can enroll in this study.
Key exclusion criteria (1 listed)
- Age of <21 and >80 years old (B) Pregnancy (C) 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
Percentage of cell lysis
Time frame: within 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Background: PubMed 11547741Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.
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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.
Wei Peng Yong, MBBS principal investigator
National University Hospital, Singapore
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 Gastric Cancer, 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 1 inclusion and 1 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 12 Jun 2015. 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?
Percentage of cell lysis (time frame: within 1 year). 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 NCT02078362, which also lists 1 linked publication.
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 12 Jun 2015.