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JOURNAL ONKOLOGIE – STUDIE
GISAR

GISAR German Interdisciplinary Sarcoma Registry

Rekrutierend

NCT-Nummer:
NCT04122872

Studienbeginn:
November 2018

Letztes Update:
18.07.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Sarcoma, Carcinosarcoma, Mixed Tumor, Mullerian

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
-

Studienleiter

Salah-Eddin Al-Batran, Prof. Dr
Study Director
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Kontakt

Daniel Pink, Dr. med.
Kontakt:
Phone: +49 33631 7
Phone (ext.): 3527
E-Mail: daniel.pink@helios-gesundheit.de
» Kontaktdaten anzeigen

Studienlocations
(3 von 18)

Interdisziplinäres Brustzentrum der Universitätsmedizin Greifswald
Ferdinand-Sauerbruch-Straße
17475 Greifswald Greifswald
(Mecklenburg-Vorpommern)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Christian Schmidt, Prof.
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Sarcomas are rare malignant tumors that affect people of all ages. They can be divided into

different subtypes yet having more than 80 different forms of soft tissue sarcomas only. In

these terms, it is not remarkable that this high number of subtypes is accompanied by various

treatment strategies, often representing multimodal treatments.

In addition, in a growing amount of patients tumors are diagnosed, whose malignant cells have

histological, cytological, or molecular properties of both epithelial tumors ("carcinoma")

and mesenchymal tumors ("sarcoma").

Such "mixed" sarcomatoid/epithelial tumors ("CS") are categorized as carcinoma considering

their epithelial origin. But in most cases, CS seem to be more aggressive, than other

carcinomas with the same origin; often they are characterized by rapid growth, invasion,

disease recurrence and metastases.

Due to the rarity of CS, only limited information is available about their clinical course

and best therapeutic approaches. Because of these uncertainties and the sarcoma-component of

the tumors, several CS-patients are referred to sarcomacenters. As many experiences with

single CS-cases as possible should be collected and evaluated to better understand the

different CS-forms.

Due to the complexity of diagnosis and therapy of sarcomas and of CS it is of high relevance

to depict the current treatment landscape and the effects and course of different treatment

options to illuminate the best option for each specific patient. This is compassed by this

registry, as it aims to collect information and data on treatment and outcome of most of

future German sarcoma cases along with retrospective data collection to achieve a most

comprehensive data set as well as the possibility to identify alterations / trends in the

procedures used for sarcoma diagnosis and therapy over time.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histological verified bone or soft tissue sarcomas including bone and soft tissue

tumors with borderline histological results or with unclear histological dignity like

giant cell tumors of the bone (GCTB), desmoid tumors, atypical lipomatous tumors etc.

- independent of therapy form and therapy line - or Histological verified sarcomatoid

carcinomas/ carcinosarcomas: tumors with histological, cytological, or molecular

properties of both epithelial tumors ("carcinoma") and mesenchymal tumors ("sarcoma")

- independent of therapy form and therapy line.

- Signed informed consent form or equivalent (s. chapter 10)

- Age ≥18 years

Exclusion Criteria:

- none

Studien-Rationale

Primary outcome:

1. Incidence of sarcoma preferably specific to the different subtypes (Time Frame - 1 year):
Generation of epidemiological data

2. Prevalence of sarcoma preferably specific to the different subtypes (Time Frame - 1 year):
Generation of epidemiological data

3. Prognosis of sarcoma preferably specific to the different subtypes (Time Frame - 1 year):
Generation of epidemiological data

Quelle: ClinicalTrials.gov


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