NCT01456455

Brief Summary

Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving CNS. Exploration of additional prognostic factors for brain involvement from gastric cancer.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

8.6 years

First QC Date

October 18, 2011

Last Update Submit

October 24, 2016

Conditions

Gastric Cancer

Keywords

Central nervous systempathological markers

Outcome Measures

Primary Outcomes (1)

  • HER2 Status

    Determination of HER2 Status on Tumor Tissue

    2 years

Secondary Outcomes (1)

  • Outcome according to HER2 Status

    2 years

Other Outcomes (1)

  • Outcome according to ethnicity of patients

    2 years

Eligibility Criteria

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

international

You may qualify if:

  • in order to be eligible for the study, the diagnosis of gastric cancer and/or lower esophageal cancer must be confirmed histologically. CNS involvement must be confirmed either via independent neuroradiological and/or positive CSF cytology.

You may not qualify if:

  • Patients whose diagnosis is not confirmed upon pathological review or where the CNS involvement cannot be confirmed after neuroradiological review will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Oncology, University Hospital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Feilchenfeldt J, Varga Z, Siano M, Grabsch HI, Held U, Schuknecht B, Trip A, Hamaguchi T, Gut P, Balague O, Khanfir K, Diebold J, Jochum W, Shoji H, Kushima R, Wagner D, Shimada Y, Cats A, Knuth A, Moch H, Aebi S, Hofer S. Brain metastases in gastro-oesophageal adenocarcinoma: insights into the role of the human epidermal growth factor receptor 2 (HER2). Br J Cancer. 2015 Sep 1;113(5):716-21. doi: 10.1038/bjc.2015.279. Epub 2015 Aug 27.

    PMID: 26313663RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

  • Silvia Hofer, MD

    University Hospital Zurich, Division of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 20, 2011

Study Start

August 1, 2011

Primary Completion

March 1, 2020

Study Completion

August 1, 2020

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)