Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer (VARIANZ)

July 10, 2018 updated by: Florian Lordick, MD, University of Leipzig

Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Adenocarcinoma of the Stomach or Gastroesophageal Junction. A Non-interventional Study

The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

549

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • University Cancer Center Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients suffer from histologically proven adenocarcinoma of the stomach or gastroesophageal junction

Description

Inclusion Criteria:

  • histologically proven adenocarcinoma of the stomach or gastroesophageal junction

    • stage IV
    • patient receives chemotherapy
    • signed informed consent
    • Age > 18 years

Exclusion Criteria:

  • Patient can not understand meaning and purpose of the study
  • patient already received a chemotherapy treatment for advanced disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response
Time Frame: 12 months
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimension of the target lesion
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time-to-progression
Time Frame: up to 24 months
The period from study entry until disease progression, death, or date of last contact.
up to 24 months
overall survival
Time Frame: up to 24 months
OS is the duration from enrollment to death.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Florian Lordick, Prof., University Cancer Center Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VARIANZ
  • 01ZX1310E (Other Grant/Funding Number: Federal Ministry of Education and Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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