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GISAR German Interdisciplinary Sarcoma Registry (GISAR)

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ClinicalTrials.gov Identifier: NCT04122872
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest

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

Condition or disease
Sarcoma Sarcoma,Soft Tissue Sarcoma of Bone Carcinosarcoma

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 9000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Years
Official Title: GISAR German Interdisciplinary Sarcoma Registry
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099


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.



Primary Outcome Measures :
  1. Incidence of sarcoma preferably specific to the different subtypes [ Time Frame: 1 year ]
    Generation of epidemiological data

  2. Prevalence of sarcoma preferably specific to the different subtypes [ Time Frame: 1 year ]
    Generation of epidemiological data

  3. Prognosis of sarcoma preferably specific to the different subtypes [ Time Frame: 1 year ]
    Generation of epidemiological data



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122872


Contacts
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Contact: Daniel Pink, Dr. med. +49 33631 7 ext 3527 daniel.pink@helios-gesundheit.de
Contact: Caroline Schönherr, Dr. +49 7601 ext 4094 schoenherr.caroline@ikf-khnw.de

Locations
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Germany
HELIOS Klinikum Bad Saarow Recruiting
Bad Saarow, Germany
Contact: Daniel Pink, Dr. med.         
Sponsors and Collaborators
IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
Investigators
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Study Director: Salah-Eddin Al-Batran, Prof. Dr IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest

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Responsible Party: IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT04122872     History of Changes
Other Study ID Numbers: GISAR
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest:
Sarcoma
Soft Tissue Sarcoma
Sarcoma of Bone
Registry
Additional relevant MeSH terms:
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Sarcoma
Carcinosarcoma
Mixed Tumor, Mullerian
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed