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

Stomach Neoplasms Clinical Trial

— VARIANZ  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305043
• Other study ID #: VARIANZ
• Secondary ID: 01ZX1310E
• Status: Completed
• Start date: March 2014
• Est. completion date: January 31, 2018

Study information

• Verified date: July 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. completion date: January 31, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Other:
• non-interventional
non-interventional

Locations

Country	Name	City	State
Germany	University Cancer Center Leipzig	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Objective Response	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	time-to-progression	The period from study entry until disease progression, death, or date of last contact.	up to 24 months
Secondary	overall survival	OS is the duration from enrollment to death.	up to 24 months