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OpenTrials
Completed

NCT Number: NCT02305043

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

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

Completed

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Cancer Center Leipzig

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

non-interventional

Primary outcomes

  1. 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

Secondary outcomes

  1. time-to-progression

    Time frame: up to 24 months

    The period from study entry until disease progression, death, or date of last contact.

  2. overall survival

    Time frame: up to 24 months

    OS is the duration from enrollment to death.

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Acronym: VARIANZ

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2014
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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