Gastric Cancer Metastasized to the Central Nervous System... | NCT01456455

Studies
Gastric Cancer Metastasized to the Central Nervous System (CNS)

NCT01456455

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Oct 25, 2016Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Mar 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Oct 18, 2011

First Submission Date that Met QC Criteria

Oct 19, 2011

First Posted Date

Oct 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

HER2 Status E-Cadherin Status

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HER2 Status	Determination of HER2 Status on Tumor Tissue	2 years

Secondary Outcomes

Measure	Description	Time Frame
Outcome according to HER2 Status		2 years

Other Outcomes

Measure	Description	Time Frame
Outcome according to ethnicity of patients		2 years

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

international

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director
Silvia Hofer, MD	University Hospital Zurich, Division of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept Oncology, University Hospital Zürich		Zurich		8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26313663	Result	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.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms