Genomic Testing and Resulting Medical Decisions

Hematologic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301493
• Other study ID #: AGMT_NGS-Registry
• Status: Recruiting
• Start date: March 30, 2017
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: Richard Greil, MD
• Phone: +43577255
• Email: r.greil[@]salk.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Cervix
• Cancer Colorectal
• Cancer Head Neck
• Cancer Liver
• Cancer of Esophagus
• Cancer of Skin
• Cancer of Stomach
• Cancer of Unknown Origin
• Cancer Refractory
• Cancer, Bladder
• Cancer, Breast
• Cancer, Kidney
• Cancer, Lung
• Cancer, Uterus
• Esophageal Neoplasms
• Head and Neck Neoplasms
• Hematologic Neoplasms
• Kidney Neoplasms
• Lung Neoplasms
• Skin Neoplasms
• Stomach Neoplasms
• Urinary Bladder Neoplasms
• Uterine Neoplasms

Intervention

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

Locations

Country	Name	City	State
Austria	Innere Medizin II, LKH Feldkirch	Feldkirch
Austria	Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck
Austria	Universitätsklinikum Krems	Krems an der Donau
Austria	BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie	Linz
Austria	IIIrd Medical Department, Private Medical University Hospital Salzburg	Salzburg
Austria	Universitätsklinikum St. Pölten	St. Pölten
Austria	Salzkammergut-Klinikum Vöcklabruck	Vöcklabruck
Austria	Klinikum Wels-Grieskirchen GmbH	Wels
Austria	Medizinische Universität Wien	Wien
Austria	St. Vinzenz Krankenhaus Betriebs GmbH	Zams

Sponsors (3)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	AstraZeneca, Roche Pharma AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types of:molecular profiling methods	To describe types of:molecular profiling methods used in the Austrian registry centres	3 years
Primary	Types of cancer, for which comprehensive molecular profiling is used	To describe types of cancer, for which comprehensive molecular profiling is used	3 years
Primary	Timing of molecular profiling	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	Number of patients with mutations identified	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
Secondary	Quality standards	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
Secondary	Treatment decisions	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
Secondary	Outcome of treatment	To describe outcome of treatment in patients receiving therapy in concordance with the test result	3 years