NCT01299688

Brief Summary

The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2013

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

February 17, 2011

Last Update Submit

January 15, 2018

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • To survey the frequency of HER2(+) CTC in gastric cancer

    24month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

metastatic gastric cancer

You may qualify if:

  • Patients older than 18 years ② Patients with localized, histologically confirmed gastric cancer ③ Informed consent form

You may not qualify if:

  • No informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, circulating tumor cell

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Won Ki Kang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

March 1, 2010

Primary Completion

March 11, 2013

Study Completion

March 11, 2013

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

KR(1)