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Esophageal NeoplasmsVARIANZNCT02305043

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

An observational study of Esophageal Neoplasms and Stomach Neoplasms, run by University of Leipzig at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Neoplasms, Stomach Neoplasms
What is being tested?
non-interventional
How many people
549 participants
Where
1 siteGermany
Study dates
Mar 2014to 31 Jan 2018
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • histologically proven adenocarcinoma of the stomach or gastroesophageal junction
  • stage IV
  • patient receives chemotherapy
  • signed informed consent
  • Age > 18 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Cancer Center Leipzig

    Leipzig, 04103

Other trials in Germany

About this study

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

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

Being tested
non-interventional
Keywords
non-interventional, advanced gastric cancer, Trastuzumab, HER2
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-interventionalOther

    non-interventional

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (2)

  1. time-to-progression

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

    Measured: up to 24 months

  2. overall survival

    OS is the duration from enrollment to death.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2018
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
549 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305043
Sponsor's protocol ID
VARIANZ
Other IDs
01ZX1310E
Acronym
VARIANZ
Status last verified
Jul 2018
First submitted
17 Nov 2014
Last updated
11 Jul 2018
Results posted
No
Data monitoring committee
No

Publications

  • Wang J, Sun N, Kunzke T, Shen J, Feuchtinger A, Wang Q, Meixner R, Gleut RL, Haffner I, Luber B, Lordick F, Walch A. Metabolic heterogeneity affects trastuzumab response and survival in HER2-positive advanced gastric cancer. Br J Cancer. 2024 Apr;130(6):1036-1045. doi: 10.1038/s41416-023-02559-6. Epub 2024 Jan 24.

    PubMed 38267634

  • Ebert K, Haffner I, Zwingenberger G, Keller S, Raimundez E, Geffers R, Wirtz R, Barbaria E, Hollerieth V, Arnold R, Walch A, Hasenauer J, Maier D, Lordick F, Luber B. Combining gene expression analysis of gastric cancer cell lines and tumor specimens to identify biomarkers for anti-HER therapies-the role of HAS2, SHB and HBEGF. BMC Cancer. 2022 Mar 9;22(1):254. doi: 10.1186/s12885-022-09335-4.

    PubMed 35264144

  • Haffner I, Schierle K, Raimundez E, Geier B, Maier D, Hasenauer J, Luber B, Walch A, Kolbe K, Riera Knorrenschild J, Kretzschmar A, Rau B, Fischer von Weikersthal L, Ahlborn M, Siegler G, Fuxius S, Decker T, Wittekind C, Lordick F. HER2 Expression, Test Deviations, and Their Impact on Survival in Metastatic Gastric Cancer: Results From the Prospective Multicenter VARIANZ Study. J Clin Oncol. 2021 May 1;39(13):1468-1478. doi: 10.1200/JCO.20.02761. Epub 2021 Mar 25.

    PubMed 33764808

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Neoplasms and Stomach Neoplasms, run by University of Leipzig at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Objective Response (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305043, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.

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