SarcomaGISARNCT04122872
GISAR German Interdisciplinary Sarcoma Registry
An observational study of Sarcoma and Sarcoma,Soft Tissue, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 21 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Sarcoma,Soft Tissue, Sarcoma of Bone
- How many people
- 9,000 participants
- Where
- 21 sitesGermany
- Study dates
- 29 Nov 2018to Jan 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Germany21 sites, 21 recruiting
- Recruiting
HELIOS Klinikum Bad Saarow
Bad Saarow
Daniel Pink, Dr. med.
- Recruiting
HELIOS Klinikum Berlin-Buch
Berlin
Peter Reichardt, Dr. med.
- Recruiting
Vivantes Klinikum Berlin-Spandau
Berlin-Spandau
Annegret Kunitz, Dr.
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Norbert Meidenbauer, Dr.
Sarah Endres
- Recruiting
Universitätsklinikum Erlangen
Erlangen
Norbert Meidenbauer, Dr.
- Recruiting
Klinikum Frankfurt Höchst
Frankfurt
Prof. Dr. Hans Guenter Derigs, Prof.
- Recruiting
Krankenhaus Nordwest KHNW
Frankfurt
Thorsten Götze, Prof.
- Recruiting
Uniklinik Freiburg
Freiburg im Breisgau
Simone Hettmer, Dr.
- Recruiting
Universitätsmedizin Göttingen
Göttingen
Florian Bösch, Dr.
- Recruiting
Universitätsmedizin Greifswald
Greifswald
Christian Schmidt, Prof.
- Recruiting
University Hospital Halle (Saale)
Halle
Christine Dierks, Prof.
- Recruiting
Asklepios Klinik St. Georg
Hamburg, 20099
Carolin Tonus, Prof. Dr.
Magdalena Karimi
- Recruiting
Uniklinikum Leipzig
Leipzig
Dirk Forstmeyer, Dr.
- Recruiting
Universitätsmedizin Mainz
Mainz
Marius Fried, Dr.
- Recruiting
Chirurgische Universitätsklinik Mannheim
Mannheim
Bernd Kasper, Prof.
- Recruiting
Westfälische Wilhelms-Universität Münster
Münster
Torsten Kessler, Dr.
- Recruiting
Klinikum Nürnberg
Nuremberg
Marinela Augustin, Dr. med.
- Recruiting
Barmherzige Brüder Regensburg
Regensburg
Nadia Maguire, Dr.
- Recruiting
Uniklinikum Regensburg
Regensburg
Matthias Grube, Dr.
- Recruiting
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Christoph K. W. Deinzer, Dr.
Gabriele Jany
- Recruiting
Universitätsklinikum Würzburg
Würzburg
Martin Kortüm, Prof.
Anna Hendricks, Dr.
About this study
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
Read the 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.
- Conditions
- Sarcoma, Sarcoma,Soft Tissue, Sarcoma of Bone, Carcinosarcoma
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Sarcoma of Bone, Registry
- Medical subject headings
- Sarcoma, Osteosarcoma, Carcinosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sarcoma preferably specific to the different subtypes
Generation of epidemiological data
Measured: 1 year
Prevalence of sarcoma preferably specific to the different subtypes
Generation of epidemiological data
Measured: 1 year
Prognosis of sarcoma preferably specific to the different subtypes
Generation of epidemiological data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start29 Nov 2018
- Primary completionJan 2038 (estimated)
- Study completionJan 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof. Dr, Study director, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122872
- Sponsor's protocol ID
- GISAR
- Acronym
- GISAR
- Status last verified
- Feb 2026
- First submitted
- 8 Oct 2019
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GISAR German Interdisciplinary Sarcoma Registry
- ClinicalTrials.gov ID
- NCT04122872
- Acronym / sponsor ID
- GISAR / GISAR
- Conditions
- Sarcoma, Sarcoma,Soft Tissue, Sarcoma of Bone, Carcinosarcoma
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Sarcoma of Bone, Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- Jan 2038 (estimated)
- Study completion
- Jan 2038 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of sarcoma preferably specific to the different subtypes
Time frame: 1 year
Generation of epidemiological data
Prevalence of sarcoma preferably specific to the different subtypes
Time frame: 1 year
Generation of epidemiological data
Prognosis of sarcoma preferably specific to the different subtypes
Time frame: 1 year
Generation of epidemiological data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salah-Eddin Al-Batran, Prof. Dr study director
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Sarcoma,Soft Tissue, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 21 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Pink, Dr. med. (+49 33631 7 ext. 3527, daniel.pink@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sarcoma preferably specific to the different subtypes (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.