GISAR German Interdisciplinary Sarcoma Registry (GISAR)

February 3, 2026 updated by: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Bad Saarow, Germany
        • Recruiting
        • Helios Klinikum Bad Saarow
        • Contact:
          • Daniel Pink, Dr. med.
      • Berlin, Germany
        • Recruiting
        • Helios Klinikum Berlin-Buch
        • Contact:
          • Peter Reichardt, Dr. med.
      • Berlin-Spandau, Germany
        • Recruiting
        • Vivantes Klinikum Berlin-Spandau
        • Contact:
          • Annegret Kunitz, Dr.
      • Erlangen, Germany
        • Recruiting
        • Universitätsklinikum Erlangen
        • Contact:
          • Norbert Meidenbauer, Dr.
      • Frankfurt, Germany
        • Recruiting
        • Klinikum Frankfurt Höchst
        • Contact:
          • Prof. Dr. Hans Guenter Derigs, Prof.
      • Frankfurt, Germany
        • Recruiting
        • Krankenhaus Nordwest KHNW
        • Contact:
          • Thorsten Götze, Prof.
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Uniklinik Freiburg
        • Contact:
          • Simone Hettmer, Dr.
      • Greifswald, Germany
        • Recruiting
        • Universitätsmedizin Greifswald
        • Contact:
          • Christian Schmidt, Prof.
      • Göttingen, Germany
        • Recruiting
        • Universitätsmedizin Göttingen
        • Contact:
          • Florian Bösch, Dr.
      • Halle, Germany
        • Recruiting
        • University Hospital Halle (Saale)
        • Contact:
          • Christine Dierks, Prof.
      • Hamburg, Germany, 20099
        • Recruiting
        • Asklepios Klinik St. Georg
        • Contact:
          • Carolin Tonus, Prof. Dr.
        • Contact:
          • Magdalena Karimi
        • Principal Investigator:
          • Carolin Tonus, Prof. Dr.
      • Leipzig, Germany
        • Recruiting
        • Uniklinikum Leipzig
        • Contact:
          • Dirk Forstmeyer, Dr.
      • Mainz, Germany
        • Recruiting
        • Universitätsmedizin Mainz
        • Contact:
          • Marius Fried, Dr.
      • Mannheim, Germany
        • Recruiting
        • Chirurgische Universitätsklinik Mannheim
        • Contact:
          • Bernd Kasper, Prof.
      • Münster, Germany
        • Recruiting
        • Westfälische Wilhelms-Universität Münster
        • Contact:
          • Torsten Kessler, Dr.
      • Nuremberg, Germany
        • Recruiting
        • Klinikum Nürnberg
        • Contact:
          • Marinela Augustin, Dr. med.
      • Regensburg, Germany
        • Recruiting
        • Barmherzige Brüder Regensburg
        • Contact:
          • Nadia Maguire, Dr.
      • Regensburg, Germany
        • Recruiting
        • Uniklinikum Regensburg
        • Contact:
          • Matthias Grube, Dr.
      • Würzburg, Germany
        • Recruiting
        • Universitätsklinikum Würzburg
        • Contact:
          • Martin Kortüm
          • Phone Number: Prof.
        • Principal Investigator:
          • Anna Hendricks, Dr.
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
          • Christoph K. W. Deinzer, Dr.
        • Contact:
          • Gabriele Jany
        • Principal Investigator:
          • Christoph K. W. Deinzer, Dr.
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
        • Principal Investigator:
          • Norbert Meidenbauer, Dr.
        • Contact:
          • Norbert Meidenbauer, Dr.
        • Contact:
          • Sarah Endres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of sarcoma preferably specific to the different subtypes
Time Frame: 1 year
Generation of epidemiological data
1 year
Prevalence of sarcoma preferably specific to the different subtypes
Time Frame: 1 year
Generation of epidemiological data
1 year
Prognosis of sarcoma preferably specific to the different subtypes
Time Frame: 1 year
Generation of epidemiological data
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2018

Primary Completion (Estimated)

January 1, 2038

Study Completion (Estimated)

January 1, 2038

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GISAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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