NCT02078362

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

December 9, 2013

Last Update Submit

June 11, 2015

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of cell lysis

    within 1 year

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Gastric cancer patients treated at National University Hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • (A) Age of \<21 and \>80 years old (B) Pregnancy (C) Decision of unsuitableness by Principal Investigator or physician-in-charge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Related Publications (1)

  • 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.

    PMID: 11547741BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wei Peng Yong, MBBS

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Peng Yong, MRCP

CONTACT

+65 6779 5555wei_peng_yong@nuhs.edu.sg

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yong Wei Peng

Study Record Dates

First Submitted

December 9, 2013

First Posted

March 5, 2014

Study Start

September 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2018

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

SG(1)