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Genomic Testing and Resulting Medical Decisions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03301493
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer of Unknown Origin Cancer Refractory Cancer of Stomach Cancer Head Neck Cancer of Skin Cancer, Lung Cancer Colorectal Cancer of Esophagus Cancer, Bladder Cancer, Uterus Cancer Cervix Cancer Liver Cancer, Kidney Cancer, Breast Hematologic Neoplasms Other: Genomic testing

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Genomic testing
    Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301493


Contacts
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Contact: Richard Greil, MD +43577255 ext 25801 r.greil@salk.at

Locations
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Austria
Innere Medizin II, LKH Feldkirch Recruiting
Feldkirch, Austria, 6807
Contact: Holger Rumpold, MD         
Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie Recruiting
Graz, Austria, A-8036
Contact: Herbert Stöger, MD         
Universitätsklinikum Krems Recruiting
Krems an der Donau, Austria, 6500
Contact: Martin Pecherstorfer, MD         
BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie Recruiting
Linz, Austria, A-4020
Contact: Andreas Petzer, MD         
IIIrd Medical Department, Private Medical University Hospital Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, MD         
St. Vinzenz Krankenhaus Betriebs GmbH Recruiting
Zams, Austria, 6511
Contact: Edward Wöll, MD         
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Roche Pharma AG
Investigators
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Principal Investigator: Richard Greil, MD IIIrd Medical Department, Private Medical University Hospital Salzburg

Additional Information:

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Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT03301493    
Other Study ID Numbers: AGMT_NGS-Registry
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Breast Neoplasms
Lung Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Urinary Bladder Neoplasms
Skin Neoplasms
Kidney Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases