Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Skin Neoplasms

Stomach Neoplasms

Head and Neck Neoplasms

Hematologic Neoplasms

Breast Neoplasms

Lung Neoplasms

Urinary Bladder Neoplasms

Kidney Neoplasms

Uterine Neoplasms

Hematologic Diseases

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Stomach Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Kidney Diseases

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Esophageal Cancer

Stomach Cancer

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

Genomic testing

Richard Greil, MD

Thomas Winder, MD

Armin Gerger, MD

Andreas Seeber, MD

Martin Pecherstorfer, MD

Andreas Petzer, MD

Petra Pichler, MD

Klaus Wilthoner, MD

Sonja Heibl, MD

Christian Singer, MD

Edward Wöll, MD

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.

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.

Genomic Testing and Resulting Medical Decisions

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

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

To describe types of cancer, for which comprehensive molecular profiling is used

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)

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

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)

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

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

Roche Pharma AG

AstraZeneca

Arbeitsgemeinschaft medikamentoese Tumortherapie

Heart and Blood Diseases

Immune System Diseases

Symptoms and General Pathology

Gland and Hormone Related Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasm Metastasis

Ovarian Neoplasms

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Sarcopenia

Neoplasms, Second Primary

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Rectal Neoplasms

Neoplasms by Histologic Type

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Neoplastic Processes

Bone Marrow Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloproliferative Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Quality of Life

Ovarian Cancer

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Myeloproliferative Disorders

Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire

Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Standard

Magali BALAVOINE

Katell LE DU, MD

Julien DOMONT, MD

Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.

Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.

Sarcopenia is defined for those under 60 years of age by LMSI\<43.1 cm²/m² for men and \<32.7 cm²/m² for women, and for patients over 60 years of age by \<38.6 cm²/m² for men and \<30.7 cm²/m² for women..

Calculated from the date of inclusion to the date of death due to any cause or the date last known to be alive if patient is censored.

Calculated from the date of start of treatment to the date of first event (progression, death, infectious complications, thrombosis, side effects of treatments of grade 2 or higher)

Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression

Calculated from the date of start of treatment for all unplanned hospitalizations for side effects of treatments of grade 2 or higher, infectious complications, thrombosis, relapse or progression

For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)

Calculated according to WHO classification

Calculated from the number of patients who were screened for sarcopenia at diagnosis in the active file of patients meeting the inclusion criteria in all participating centers

Weprom

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Genomic Testing and Resulting Medical Decisions	NCT03301493	Cancer of Unkno... Cancer Refracto... Cancer of Stoma... Cancer Head Nec... Cancer of Skin Cancer, Lung Cancer Colorect... Cancer of Esoph... Cancer, Bladder Cancer, Uterus Cancer Cervix Cancer Liver Cancer, Kidney Cancer, Breast Hematologic Neo...	Genomic testing	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy	NCT05154474	Metastatic Canc... Cancer, Breast Cancer Colon Cancer, Rectum Cancer, Lung Cancer Ovaries Cancer Prostate Cancer, Kidney Cancer Pancreas Myeloma Myelodysplasia Leukemia, Myelo... Leukemia,Myeloi... Leukemia, Lymph... Leukemia, Lymph...	Standard	18 Years -	Weprom

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