Genomic Testing and Resulting Medical Decisions

April 9, 2025 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.

In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.

The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Richard Greil, MD
  • Phone Number: 25801 +43577255
  • Email: r.greil@salk.at

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • Innere Medizin II, LKH Feldkirch
      • Graz, Austria, A-8036
        • Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Krems an der Donau, Austria, 6500
        • Universitätsklinikum Krems
      • Linz, Austria, A-4020
        • BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie
      • Salzburg, Austria, 5020
        • IIIrd Medical Department, Private Medical University Hospital Salzburg
      • St. Pölten, Austria, 3100
        • Universitätsklinikum St. Pölten
      • Vöcklabruck, Austria, 4840
        • Salzkammergut-Klinikum Vöcklabruck
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
      • Wien, Austria, 1090
        • Medizinische Universität Wien
      • Zams, Austria, 6511
        • St. Vinzenz Krankenhaus Betriebs GmbH

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A cohort of oncology patients who received or plan to receive comprehensive genomic testing anytime on or after January 1, 2016. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.

Description

Inclusion Criteria:

This registry will include cancer patients for which broad genomic profiling is indicated as assessed by the medical need and as deemed appropriate by the physician, for example

  • cancer with high mutational load and suspicion of regular or frequent formation of neoantigens

    • skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head and neck, kidney, breast
    • lymphoma B-cell
  • any other neoplastic disease where molecular targeting is performed but treatment fails
  • cancer of unknown primary origin (CUP)
  • planned or already carried out comprehensive genomic testing as of Jan 1, 2016 note: this registry will not initially register patients who are tested for only 1-5 mutations by conventional means, but patients undergoing genomic profiling based on NGS)
  • a patient´s signed informed consent
  • Patients ≥ 18 years of age

Exclusion Criteria:

  • Due to the non-interventional design of the registry there are no specific exclusion criteria.

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

  • Observational Models: Other
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Types of:molecular profiling methods
Time Frame: 3 years
To describe types of:molecular profiling methods used in the Austrian registry centres
3 years
Types of cancer, for which comprehensive molecular profiling is used
Time Frame: 3 years
To describe types of cancer, for which comprehensive molecular profiling is used
3 years
Timing of molecular profiling
Time Frame: 3 years
To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with mutations identified
Time Frame: 3 years

To describe targets identified:

  • number of patients with at least one mutation identified
  • number of patients with at least one druggable target identified
  • number of patients with more than one druggable targets identified
  • number of druggable targets per cancer type
3 years
Quality standards
Time Frame: 3 years

To describe tests used and quality standards:

  • to compare results of NGS based molecular test systems with single marker tests or small gene panel tests
  • quality standards of the test methods used (TAT, certification status)
  • to evaluate development of methods used over time
  • usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)
3 years
Treatment decisions
Time Frame: 3 years

To describe treatment decisions:

  • frequency by which treatment decision follows the result of NGS testing
  • frequency with druggable targets with available on-label therapy option
  • treatment decisions in the presence of more than one druggable target
3 years
Outcome of treatment
Time Frame: 3 years
To describe outcome of treatment in patients receiving therapy in concordance with the test result
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arbeitsgemeinschaft medikamentoese Tumortherapie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Greil, MD, IIIrd Medical Department, Private Medical University Hospital Salzburg

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGMT_NGS-Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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