Gastric Cancer Metastasized to the Central Nervous System (CNS)

Gastric Cancer Clinical Trial

Official title:

Registry of Gastric Cancer and Brain Metastases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01456455
• Other study ID #: UGICNS
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: October 24, 2016
• Start date: August 2011
• Est. completion date: August 2020

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

HER2 Status E-Cadherin Status

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: August 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Switzerland	Dept Oncology, University Hospital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & 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-oesop — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Outcome according to ethnicity of patients		2 years	No
Primary	HER2 Status	Determination of HER2 Status on Tumor Tissue	2 years	No
Secondary	Outcome according to HER2 Status		2 years	No