GISAR German Interdisciplinary Sarcoma Registry

Sarcoma Clinical Trial

— GISAR  

Official title:

GISAR German Interdisciplinary Sarcoma Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122872
• Other study ID #: GISAR
• Status: Recruiting
• Start date: November 29, 2018
• Est. completion date: January 2038

Study information

• Verified date: July 2023
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: Daniel Pink, Dr. med.
• Phone: +49 33631 7
• Email: daniel.pink[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

GISAR has an open and modular setup. It is sought to include as many German sarcoma and CS patients (i.e. sarcoma and CS patients treated in Germany) in the registry as possible. A basic data set should be collected on every included patient). In order to adress specific scientific questions, additionally detailed data can be collected in defined patient groups (e.g. effectiveness / adverse effects of systemic therapies in defined situations) within the context of sub-project add-on modules. This data collection can be prospective or retrospective depending on the sub-project

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9000
• Est. completion date: January 2038
• Est. primary completion date: January 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinosarcoma
• Mixed Tumor, Mullerian
• Sarcoma
• Sarcoma of Bone
• Sarcoma,Soft Tissue

Locations

Country	Name	City	State
Germany	HELIOS Klinikum Bad Saarow	Bad Saarow
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Vivantes Klinikum Berlin-Spandau	Berlin-Spandau
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Klinikum Frankfurt Höchst	Frankfurt
Germany	Krankenhaus Nordwest KHNW	Frankfurt
Germany	Uniklinik Freiburg	Freiburg
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	University Hospital Halle (Saale)	Halle
Germany	Uniklinikum Leipzig	Leipzig
Germany	Universitätsmedizin Mainz	Mainz
Germany	Chirurgische Universitätsklinik Mannheim	Mannheim
Germany	Westfälische Wilhelms-Universität Münster	Münster
Germany	Klinikum Nürnberg	Nürnberg
Germany	Barmherzige Brüder Regensburg	Regensburg
Germany	Uniklinikum Regensburg	Regensburg
Germany	Universitätsklinikum Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sarcoma preferably specific to the different subtypes	Generation of epidemiological data	1 year
Primary	Prevalence of sarcoma preferably specific to the different subtypes	Generation of epidemiological data	1 year
Primary	Prognosis of sarcoma preferably specific to the different subtypes	Generation of epidemiological data	1 year