Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GISAR German Interdisciplinary Sarcoma Registry (GISAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122872
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Tracking Information
First Submitted Date October 8, 2019
First Posted Date October 10, 2019
Last Update Posted Date December 4, 2020
Actual Study Start Date November 29, 2018
Estimated Primary Completion Date January 2038   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title GISAR German Interdisciplinary Sarcoma Registry
Official Title GISAR German Interdisciplinary Sarcoma Registry
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
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition
  • Sarcoma
  • Sarcoma,Soft Tissue
  • Sarcoma of Bone
  • Carcinosarcoma
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 9, 2019)
9000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2038
Estimated Primary Completion Date January 2038   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Daniel Pink, Dr. med. +49 33631 7 ext 3527 daniel.pink@helios-gesundheit.de
Contact: Bianca Zäpf +49 7601 ext 4636 zaepf.bianca@ikf-khnw.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04122872
Other Study ID Numbers GISAR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No IPD will be shared
Responsible Party Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators Not Provided
Investigators
Study Director: Salah-Eddin Al-Batran, Prof. Dr Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
PRS Account Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Verification Date December 2020