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Alle Register


Register: AGMT ALL_Reg |  AGMT BC_Met_Reg |  AGMT GASTRIC 5_Reg |  AGMT HMA®_Reg |  AGMT HNO_Reg |  AGMT KRAS_Reg |  AGMT LMR_Reg |  AGMT_AIHA-Reg |  AGMT_BV-Reg |  AGMT_MBC-Registry |  AGMT_NGS_Reg |  AGMT_NHL-14_Reg |  AGMT_PTCL-Reg | 

 


AGMT ALL_Reg

Coordinating Investigator: Prof. Dr. Ulrich Jäger
Fallzahl: 70/Jahr
Start: Q3 2012 | Ende: nicht festgelegt
Status: recruiting


Registry and Biobank for the collection of clinical data and biomaterial from adult ALL patients

Studiendesign

This registry is a retrospective and prospective, observational, multi-centre research initiative. Data will be collected from all sites in Austria willing to participate.

Studienziele

The aim of the ALL registry is to collect data regarding diagnosis, therapy and progression of disease for all Austrian ALL patients older than 18 years. These data should be collected during clinical routine treatment of the patients.
Following data should be collected:
• Baseline data like initial diagnostic including subtype of ALL, histology, prognostic factors, immunophenotyp, cytology, molecular diagnostic
• Induction therapy, SCT, experimental treatment
• Supportive therapies
• Inclusion in clinical studies
• Response including MRD
• Comorbidity
• Quality of life

Einschlusskriterien (Auszug)

Age 18 or older
• Patient\'s written informed consent
• Acute lymphoblastic leukaemia (all types according WHO classification 2008)
• Diagnosis of specific NHL subtypes (WHO classification) :
B-lymphoblastic lymphoma
T-lymphoblastic lymphoma
Burkitt´s lymphoma
Aggressive lymphoma with c-myc translocation
Other high risk lymphomas treated with ALL protocols

URL-Link

http://ecrf.ibdis.net

Link to online CRF

Public Downloads

AGMT ALL Register Poster
Poster am OeGHO 2017





AGMT BC_Met_Reg

Coordinating Investigator: Prof. Dr. R. Greil / Doz. Dr. B. Mlineritsch
Fallzahl: 50
Start: Q1 2011 | Ende: Q4 2016
Status: recruiting


Surgical Resection of Solitary Metastases in Patients with Metastatic Breast Cancer

Studiendesign

This Registry is a retrospective and prospective, observational, multi-center research initiative. Data will be collected from all sites in Austria willing to participate.

Studienziele

• number of patients who have metastases resection
• Overall survival

Einschlusskriterien (Auszug)

Physicians will select appropriate patients for enrollment.
Appropriate patients are expected to:
• have BC with metastases, which are already surgically removed or are planned to be surgically removed
• be willing to provide informed consent

Due to the non-interventional design of this program there are no specific in- or exclusion criteria.

URL-Link

http://ecrf.ibdis.net

Link to online CRF





AGMT GASTRIC 5_Reg

Coordinating Investigator: Prim. Doz. Dr. Ewald Wöll
Fallzahl: 200-300
Start: 28.03.2011 | Ende: Q4 2017
Status: recruiting


Screening for human epidermal growth factor receptor 2 (HER2) positivity in patients with inoperable locally advanced or metastatic gastric or gastro-esophageal junction (GEJ) cancer

Studiendesign

This Registry is a prospective, observational, multi-center research initiative. Data will be collected from all sites in Austria willing to participate.

Studienziele

• rate of HER2 positive locally advanced or metastatic gastric or GEJ cancer

additional objectives:

• comparison of HER2 results from local and central labs
• safety of chemoimmunotherapy in HER2 positive patients
• progression-free survival time after treatment with chemoimmunotherapy
• overall survival time after treatment with chemoimmunotherapy

Einschlusskriterien (Auszug)

Physicians will select appropriate patients for enrolment.
Appropriate patients are expected to:

• have locally advanced or metastatic gastric or GEJ carcinoma
• be tested for their HER2 status
• be willing to provide informed consent

Due to the non-interventional design of this program there are no specific in- or exclusion criteria.

URL-Link

http://ecrf.ibdis.net

Link online CRF

Public Downloads

Gastric 5_Reg. Folder
Kurzbeschreibung

AGMT GASTRIC 5 Register Poster
Poster am OeGHO 2017





AGMT HMA®_Reg

Coordinating Investigator: Prof. Dr. Richard Greil / PD Dr. Lisa Pleyer
Fallzahl: 800-1000
Start: Q1 2009 | Ende: NA
Status: recruiting


AGMT – Austrian Registry on Hympomethylating Agents in Myeloid Neoplasms

Studiendesign

This Registry is a retrospective and prospective, observational, multi-center research initiative. Data will be collected from all sites willing to participate. It is expected, that the main data-bulk will be obtained from approximately 20 sites. An estimated 800-1000 patients are expected to be included; these numbers may be revised over time as interest and demand dictates.

Studienziele

• Number of Cycles and Dosage of DACOGEN® or VIDAZA® therapy
• Response evaluation:
• hematological response
• cytogenetic response (if data is available)
• quantification of reduced need for transfusions
• median response duration
• Toxicites:
o Grade
o Duration
o Consequences:
Hospitalization, treatment, etc.
Dose modifications or treatment discontinuations of hypomethylating agent
• Severe adverse reactions
• Overall survival
• Prognostic factors for overall survival and response

Einschlusskriterien (Auszug)

Physicians will select appropriate patients for enrollment. Appropriate patients are expected to: Begin with or already have received treatment with DACOGEN® or VIDAZA®
Be willing to provide informed consent

Due to the non-interventional design of this program there are no specific in- or exclusion criteria.
VIDAZA® is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. VIDAZA® is also contraindicated in patients with advanced malignant hepatic tumors. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with VIDAZA®. Women treated with VIDAZA® should not nurse. Men should be advised to not father a child while receiving treatment with VIDAZA®.

DACOGEN® is contraindicated in patients with a known hypersensitivity to decitabine or Kaliumdihydrogenphosphat (E340) or Natriumhydroxid (E524). Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with DACOGEN®. Women treated with DACOGEN® should not nurse. Men should be advised to not father a child while receiving treatment with DACOGEN®.

URL-Link

http://ecrf.ibdis.net

Link to online CRF

Public Downloads

AGMT HMA Register Poster
Poster am OeGHO 2017





AGMT HNO_Reg

Coordinating Investigator: Prof. Dr. Richard Greil, Prof. Dr. Gabriela Kornek
Fallzahl: 500
Start: Q2 2011 | Ende: Q4 2016
Status: recruiting


Prospektive Datenerhebung der Therapie bei Patienten mit lokal fortgeschrittenen und rezidivierenden/metastasierenden Kopf-Hals-Tumoren

Studiendesign

Dieses Register ist als prospektiv beobachtende multizentrische Erhebung angelegt. Die Daten werden über einen Zeitraum von 10 Jahren in allen österreichischen Zentren erhoben, die ihre Zustimmung zur Teilnahme geben.

Studienziele

• Erhebung der Behandlungsrealität in Österreich
• Sequenzen der Behandlung Stadien-spezifisch
• Therapiewahl in den jeweiligen Behandlungslinien und Lokalisationen
• Response-Evaluierung: Messung von RR, PFS und OS

Einschlusskriterien (Auszug)

Die Selektion geeigneter Patienten erfolgt durch die Prüfärzte in den einzelnen Zentren:

Geeignete Patienten sind:
• Patienten mit eindeutig diagnostizierten Tumoren der Kopf-Hals-Region
• Patienten, die mit dieser Datenerhebung ausdrücklich einverstanden sind

Aufgrund des nicht-Interventionellen Designs des Registers sind keine spezifischen Ein-/Ausschlußkriterien definiert.

URL-Link

http://www.hno-registry.com

Link online CRF

Public Downloads

AGMT HNO_Reg Poster
Poster am OeGHO 2016





AGMT KRAS_Reg

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 295
Start: Q3 2010 | Ende: Q1 2016
Status: completed


Biomarkers in Metastatic Colorectal Cancer

Studiendesign

This Registry is a retrospective and prospective, observational, multi-center research initiative. Data will be collected from all sites in Austria willing to participate.

Studienziele

• Standards of KRAS testing in Austria
• Standards of P53 testing (at selected sites)
• Response
• Progression free survival
• Overall survival

Einschlusskriterien (Auszug)

Physicians will select appropriate patients for enrolment.
Appropriate patients are expected to:
• have mCRC
• shall be tested for their KRAS status (or already have been tested)
• be willing to provide informed consent

Due to the non-interventional design of this program there are no specific in- or exclusion criteria.

URL-Link

http://www.kras-registry.com

Link to online CRF





AGMT LMR_Reg

Coordinating Investigator: Prof. Dr. Dietmar Öfner / Prof. Dr. Richard Greil
Fallzahl: 40
Start: Q4 2010 | Ende: Q4 2016
Status: recruiting


Chirurgische Resektion von Lebermetastasen

Studiendesign

Dieses Register ist eine prospektiv und retrospektiv beobachtende, multizentrische Erhebung. Die Daten werden in allen österreichischen Zentren erhoben, die ihre Zustimmung zur Teilnahme geben. Zusätzlich sollen in näherer Zukunft auch deutsche Zentren Daten in dieses Register eingeben.

Studienziele

• PFS
• OS
• DFS

Einschlusskriterien (Auszug)

Die Selektion geeigneter Patienten erfolgt durch die Prüfärzte in den einzelnen Zentren:

Geeignete Patienten sind:
• Patienten mit resektablen Lebermetastasen, unabhängig von der Lokalisation des Primums
• Patienten, die mit dieser Datenerhebung ausdrücklich einverstanden sind

Aufgrund des nicht-Interventionellen Designs des Registers sind keine spezifischen Ein-/Ausschlußkriterien definiert.

URL-Link

http://ecrf.ibdis.net

Link to online CRF





AGMT_AIHA-Reg

Coordinating Investigator: Prof. Dr. Ulrich Jäger
Fallzahl: 100
Start: Q3 2016 | Ende: NA
Status: recruiting


Autoimmune hemolytic anemia (AIHA) Registry

Studiendesign

This registry is a prospective and retrospective, multicentre collection of data on patients with AIHA in Austria. All disease characteristics, medical histories and also treatment sequences are documented in anonymised form.
To help maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrolment; this number will accompany the patient\'s medical and other registry information throughout the lifetime of the registry and biobank.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

In addition biomaterial should be collected in a biobank to provide a basis for future AIHA related research. A centralised biobank is the appropriate tool to collect these materials under strict ethical and legal regulations.
Subsequently, the biomaterial will also be transferred for scientific purpose to different specialised laboratories in Austria and abroad.

Data will be collected from all sites in Austria willing to participate. An estimated 100 patients are expected to be included; this number may be revised over time as interest and demand dictates.

Electronic Case Report Forms will be used for data collection.

Studienziele

The aim of the AIHA registry is to collect data regarding the following objectives of disease for all Austrian AIHA patients older than 18 years.

• Epidemiological evaluations
o Assessment of AIHA subtypes in Austria
o Assessment of specific characteristics and frequency of AIHA
• Patient care and treatment in Austria
o Treatments used, sequence of treatments
o Efficacy and toxicity

• Establishment of a central biobank to provide a basis for future AIHA related research

Identification of further objectives

The broad range of data collected within the scope of the AGMT AIHA registry provides the possibility to identify and address further objectives.

Einschlusskriterien (Auszug)

• Age 18 years or over
• Clinical and laboratory signs of AIHA

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

Public Downloads

AGMT AIHA Register Poster
Poster am OeGHO 2017





AGMT_BV-Reg

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 100
Start: Q3 2016 | Ende: NA
Status: planned


Austrian Brentuximab Vedotin Registry

Studiendesign

This Registry is a prospective and retrospective, observational, multi-center research initiative. Data will be collected from all sites in Austria willing to participate.

100 patients in 5 years are planned. According to the Austrian office of statistic (Statistik Austria) this would be about 50% of the patients that qualify for BV treatment in this period.

To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrolment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.

Electronic Case Report Forms will be used for data collection.

Associated with the registry a central biobank should be established for the collection of biosamples. These samples will be collected within normal clinical routine, no additional sampling or bone marrow punctuations will be necessary.
The collection of biomaterial is not categorical connected to the registry.

Studienziele

The objective of this registry is to evaluate the use, efficacy and toxicity of Brentuximab vedotin (BV) in Hodgkin´s disease (HD) and systemic anaplastic large cell lymphoma sALCL according to WHO 2008 in Austria and to identify the duration of therapy in these indications.

Further objectives are the evaluation of Progression free and Overall Survival (PFS and OS).

Einschlusskriterien (Auszug)

Physicians will select appropriate patients for enrolment.
Appropriate patients are expected to:
• Patients with Hodgkin's disease and PTCL (sub-entity sALCL) (according to the WHO 2008 classification) who are willing to participate and will receive BV therapy

Due to the non-interventional design of this program there are no specific in- or exclusion criteria.





AGMT_MBC-Registry

Coordinating Investigator: Prof. Dr. Richard Greil
Fallzahl: 1500-3000
Start: Q2 2015 | Ende: Q1 2025
Status: recruiting


Metastatic breast cancer in Austria

Studiendesign

This registry is a prospective and retrospective, multicentre collection of data on patients with metastatic breast cancer in Austria. All tumour
characteristics, medical histories and also treatment sequences are documented in anonymised form. For documentation in the registry, no
further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Studienziele

Epidemiological evaluations:
• General characteristics of metastatic stage patients in Austria
• Assessment of metastatic stage breast cancer subtypes in Austria
• Assessment of the specific characteristics and frequency of metastatic breast cancer
• Data on survival of female patients with metastatic breast cancer in Austria
• Assessment of metastatic breast cancer therapies in Austria
• Assessment of therapy response outside clinical studies
a) First-line therapy
b) Second-line therapy
c) Third and higher lines of therapy

Specific questions:
Specific questions are also investigated, such as the frequency of histology preparations from metastases, the frequency of histological discrepancies between primary tumour and metastasis, the importance of metastasis surgery and operation of the primary tumour in primary metastatic breast cancer.

Einschlusskriterien (Auszug)

• Histological evidence of breast cancer
• Histological and/or radiological evidence of metastases
• Metastasis within 10 years of registry initiation
• Signed informed consent (if a patient has already died at the time
of entry, the entry can be made without a declaration of consent)

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

URL-Link

http://www.mbc-register.at

Link to online CRF

Public Downloads

AGMT MBC Register Poster
Poster am OeGHO 2017





AGMT_NGS_Reg

Coordinating Investigator: Univ.-Prof. Dr. Richard Greil
Fallzahl: 500
Start: Q1 2017 | Ende: Q4 2019
Status: recruiting


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

Studiendesign

This registry is designed as multicenter non-interventional (observational) cohort of oncology patients who received or plan to receive comprehensive genomic testing. 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.
The registry will be made available for all disciplines and physicians caring for cancer patients. Indications for genomic testing are exclusively driven by the medical need. Physicians are free to use any type of genomic test available at their hospital or from any company. The decision to use comprehensive genomic testing must be clearly separated from the decision to include the patient in the registry.

Studienziele

The goal of this registry is to landscape the clinical practice of molecular profiling in Austrian cancer patients with focus on identification of methods used, evaluation when the tests are performed in the course of the disease, and definition of the impact of the test result on the subsequent treatment decision.

Einschlusskriterien (Auszug)

This registry will include cancer patients for which broad genomic profiling is indicated, 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)

Further inclusion criteria:
• planned or already carried out comprehensive genomic testing as of Jan 1, 2016
• Signed written informed consent, age 18 years or over

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.

Public Downloads

AGMT NGS Register Poster
Poster am OeGHO 2017





AGMT_NHL-14_Reg

Coordinating Investigator: Univ. Doz. Dr. Michael A. Fridrik
Fallzahl: 94
Start: Q4 2012 | Ende: Q3 2023
Status: active, not recruiting


Nachbeobachtung der Patienten der AGMT_NHL-14 Studie:

Studiendesign

Dieses Register ist eine prospektive, multizentrische Beobachtungsstudie.
Die Follow-up Daten der Patienten der NHL-14 Studie werden dabei gesammelt.

Studienziele

Klinische Zeichen einer Herzinsuffizienz
Messung der Auswurffraktion (optional)
Messung NT-proBNP (optional)
Auftreten von Sekundärmalignomen
Auftreten von Rezidiven
Todesfall

Einschlusskriterien (Auszug)

Patienten, die im Rahmen der NHL 14 Studie behandelt wurden, werden über das Register aufgeklärt und gebeten, eine Patienteninformation zu unterzeichnen.
Da es sich um eine nicht-interventionelle Studie handelt, werden keine spezifischen Ein- und Ausschlusskriterien definiert





AGMT_PTCL-Reg

Coordinating Investigator: Prof. Dr. Richard Greil / PROTOCOL CONTACT PERSON: Dr. Lukas Weiss
Fallzahl:
Start: Q2 2013 | Ende: Q4 2018
Status: recruiting


Erhebung epidemiologischer Daten von T-Zell Lymphomen in Österreich

Studiendesign

Dieses Register ist eine sowohl prospektiv als auch retrospektiv beobachtende, multizentrische Erhebung. Die Daten werden in allen österreichischen Zentren erhoben, die ihre Zustimmung zur Teilnahme geben.
Für diese Dokumentation sind keine diagnostischen und therapeutischen Maßnahmen erforderlich, die über den ohnehin notwendigen und üblichen Rahmen hinausgehen. Durch die Dokumentation soll die Behandlungsroutine nicht verändert werden.
Die Sammlung der Daten erfolgt über ein elektronisches Datenerfassungssystem.
Zusätzlich soll zukünftig im Rahmen des Registers von allen Patienten, die dazu Ihr Einverständnis geben, Biomaterial gesammelt und zentral gelagert werden, um eine Basis für zukünftige wissenschaftliche Untersuchungen von krankheitsspezifischen Parametern zu schaffen.

Wichtige Änderungen ab September 2015:
• Kooperation mit dem "T-cell project" (TCP) der italienischen Studiengruppe (Associazione Angela Serra per la ricerca sul cancro, Prof. Massimo Federico, Università die Modena)
• Einschluss von jugendlichen Patienten (≥ 12 Jahre)
• Retrospektiver Einschluss von Patienten möglich
• Umfangreiche Erfassung aller vorliegenden Biomaterialien (einschließlich Keimbahn-Probennahmen, hämatopoietische Stammzellen, etc.)

Studienziele

• Verteilungsmuster (2008-WHO-Klassifikation)
• Therapien
• Ansprechen
• Biobanking

Einschlusskriterien (Auszug)

• Patienten mit einem peripheren T-Zell-Lymphom (PTCL) laut 2008-WHO-Klassifikation
• Alter ≥ 12 Jahre
• Patienten, die mit dieser Datenerhebung ausdrücklich einverstanden sind


Aufgrund des nicht-Interventionellen Designs des Registers sind keine spezifischen Ein-/Ausschlußkriterien definiert.

URL-Link

https://ecrf.ibdis.net/

Link zum Online-CRF

Public Downloads

AGMT PTCL Register Poster
Poster am OeGHO 2017