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NCT Number: NCT03301493

Genomic Testing and Resulting Medical Decisions

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.

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Key information

Conditions

Cancer of Unknown Origin Adenocarcinoma Breast Diseases Breast Neoplasms Cancer Cervix Cancer Colorectal Cancer Head Neck Cancer Liver Cancer Refractory Cancer of Esophagus Cancer of Skin Cancer of Stomach Cancer, Bladder Cancer, Breast Cancer, Kidney Cancer, Lung Cancer, Uterus Carcinoma Carcinoma, Hepatocellular Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Unknown Primary Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IIIrd Medical Department, Private Medical University Hospital Salzburg, Salzburg, State of Salzburg, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Genomic testing

Other

Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice

Primary outcomes

  1. Types of:molecular profiling methods

    Time frame: 3 years

    To describe types of:molecular profiling methods used in the Austrian registry centres

  2. 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. 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)

Secondary outcomes

  1. 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

  2. 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. 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

  4. Outcome of treatment

    Time frame: 3 years

    To describe outcome of treatment in patients receiving therapy in concordance with the test result

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • AstraZeneca
  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Oct 4, 2017
Registry last updated
Apr 10, 2025

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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