GISAR German Interdisciplinary Sarcoma Registry

NCT ID: NCT04122872

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-29

Study Completion Date

2038-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Sarcoma Sarcoma,Soft Tissue Sarcoma of Bone Carcinosarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with bone or soft tissue sarcomas or carcinosarcomas

Adults ≥18 years, verified for 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) as well as carcinosarcomas - independent of kind of therapy and therapy line. Thus, the registry is open for all subtypes of sarcomas and CS.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salah-Eddin Al-Batran, Prof. Dr

Role: STUDY_DIRECTOR

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Locations

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Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

HELIOS Klinikum Bad Saarow

Bad Saarow, , Germany

Site Status RECRUITING

HELIOS Klinikum Berlin-Buch

Berlin, , Germany

Site Status RECRUITING

Vivantes Klinikum Berlin-Spandau

Berlin-Spandau, , Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Klinikum Frankfurt Höchst

Frankfurt, , Germany

Site Status RECRUITING

Krankenhaus Nordwest KHNW

Frankfurt, , Germany

Site Status RECRUITING

Uniklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status RECRUITING

Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status RECRUITING

University Hospital Halle (Saale)

Halle, , Germany

Site Status RECRUITING

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status RECRUITING

Uniklinikum Leipzig

Leipzig, , Germany

Site Status RECRUITING

Universitätsmedizin Mainz

Mainz, , Germany

Site Status RECRUITING

Chirurgische Universitätsklinik Mannheim

Mannheim, , Germany

Site Status RECRUITING

Westfälische Wilhelms-Universität Münster

Münster, , Germany

Site Status RECRUITING

Klinikum Nürnberg

Nuremberg, , Germany

Site Status RECRUITING

Barmherzige Brüder Regensburg

Regensburg, , Germany

Site Status RECRUITING

Uniklinikum Regensburg

Regensburg, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniel Pink, Dr. med.

Role: CONTACT

+49 33631 7 ext. 3527

Bianca Zäpf

Role: CONTACT

+49 7601 ext. 4636

Facility Contacts

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Christoph K. W. Deinzer, Dr.

Role: primary

Gabriele Jany

Role: backup

Norbert Meidenbauer, Dr.

Role: primary

Sarah Endres

Role: backup

Daniel Pink, Dr. med.

Role: primary

Peter Reichardt, Dr. med.

Role: primary

Annegret Kunitz, Dr.

Role: primary

Norbert Meidenbauer, Dr.

Role: primary

Prof. Dr. Hans Guenter Derigs, Prof.

Role: primary

Thorsten Götze, Prof.

Role: primary

Simone Hettmer, Dr.

Role: primary

Florian Bösch, Dr.

Role: primary

Christian Schmidt, Prof.

Role: primary

Christine Dierks, Prof.

Role: primary

Carolin Tonus, Prof. Dr.

Role: primary

Magdalena Karimi

Role: backup

Dirk Forstmeyer, Dr.

Role: primary

Marius Fried, Dr.

Role: primary

Bernd Kasper, Prof.

Role: primary

Torsten Kessler, Dr.

Role: primary

Marinela Augustin, Dr. med.

Role: primary

Nadia Maguire, Dr.

Role: primary

Matthias Grube, Dr.

Role: primary

Martin Kortüm

Role: primary

Prof.

Other Identifiers

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GISAR

Identifier Type: -

Identifier Source: org_study_id

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