NCT04122872

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
141mo left

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Nov 2018Jan 2038

Study Start

First participant enrolled

November 29, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
18.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2038

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

19.1 years

First QC Date

October 8, 2019

Last Update Submit

February 3, 2026

Conditions

Keywords

SarcomaSoft Tissue SarcomaSarcoma of BoneRegistry

Outcome Measures

Primary Outcomes (3)

  • Incidence of sarcoma preferably specific to the different subtypes

    Generation of epidemiological data

    1 year

  • Prevalence of sarcoma preferably specific to the different subtypes

    Generation of epidemiological data

    1 year

  • Prognosis of sarcoma preferably specific to the different subtypes

    Generation of epidemiological data

    1 year

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

HELIOS Klinikum Bad Saarow

Bad Saarow, Germany

RECRUITING

HELIOS Klinikum Berlin-Buch

Berlin, Germany

RECRUITING

Vivantes Klinikum Berlin-Spandau

Berlin-Spandau, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Germany

RECRUITING

Klinikum Frankfurt Höchst

Frankfurt, Germany

RECRUITING

Krankenhaus Nordwest KHNW

Frankfurt, Germany

RECRUITING

Uniklinik Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, Germany

RECRUITING

Universitätsmedizin Greifswald

Greifswald, Germany

RECRUITING

University Hospital Halle (Saale)

Halle, Germany

RECRUITING

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

RECRUITING

Uniklinikum Leipzig

Leipzig, Germany

RECRUITING

Universitätsmedizin Mainz

Mainz, Germany

RECRUITING

Chirurgische Universitätsklinik Mannheim

Mannheim, Germany

RECRUITING

Westfälische Wilhelms-Universität Münster

Münster, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, Germany

RECRUITING

Barmherzige Brüder Regensburg

Regensburg, Germany

RECRUITING

Uniklinikum Regensburg

Regensburg, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

formalin-fixed paraffin-embedded tumor tissue

MeSH Terms

Conditions

SarcomaOsteosarcomaCarcinosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Complex and Mixed

Study Officials

  • Salah-Eddin Al-Batran, Prof. Dr

    Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

November 29, 2018

Primary Completion (Estimated)

January 1, 2038

Study Completion (Estimated)

January 1, 2038

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations