Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry)

August 24, 2022 updated by: Klinikum Stuttgart

Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry)

The Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry) is a non-interventional, multicentric, international, clinical and epidemiologic patient registry. The COSS-Registry collects key data on osteosarcomas or biologically related bone sarcomas. With that data collection we want to gain new scientific insights and results about this tumor disease, prognosis, surveillance and long-term effects.

Besides the data collection we would also like to foster the collection of biomaterial (tumor specimen and blood samples) for scientific research.

The stored material will be used to perform cell and molecular biological analyses to identify the causes of osteosarcoma, the prognosis and possible new treatment options.

As a starting point the donated biomaterial of registered patients will be analyzed firstly for the presence of a tumor predisposition by germline mutations.

In case of detected genetic variations that are related to the tumor disease and which may affect the patient's health and follow-up care (because of the potentially increased risk of developing other malignant tumors), affected patients will be informed and referred to genetic counseling.

Registry patients will be asked at the time of diagnosis if they wish to be informed about germline variants detected as part of the study procedures.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Osteosarcomas are rare and malignant bone tumors with an incidence of only 200-300 diagnoses in Germany each year. The biological behaviour of the tumor is not well understood yet. Treatment options and survival prognosis have not improved for the last decades.

The planned collection of treatment and follow-up data of affected patients at the COSS-Registry has the goal to gain further insights about this tumor, to improve survival rates and to identify possible germline variants in tumor predisposition genes in any patient diagnosed with OS.

It is also necessary to foster research on the genetic and molecular biological characteristics of osteosarcoma by analyzing biomaterial samples (especially tumor tissue) for example to identify new therapy targets or to evaluate the response to and the adverse effects of chemotherapy with respect to the germline alterations.

Therefore a substantial amount of biomaterial has to be gathered and stored in a biobank. Accompanying to the COSS-Registry's data collection, biological samples taken from registered patients during routine measures and which are no longer required for further treatment will be stored in the COSS-Biobank.

The biological samples collected will be used to carry out genetic tests to check for an underlying tumor predisposition by germline mutations and for a next-generation sequencing of the whole genome. The goal of this project is to prospectively characterize the germline genetics in OS patients, to increase the understanding of the impact of germline alterations on the age of manifestation of OS, to evaluate the response to and the adverse effects of chemotherapy with respect to the germline alterations and to integrate germline investigation and counselling into the routine workup of any child, adolescent or young adult diagnosed with OS registered at the COSS-Registry.

In this way, affected patients will benefit from their participation in the COSS-Registry and COSS-Biobank.

Study Type

Observational

Enrollment (Anticipated)

1000

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients irrespective of gender, age and tumour location

Description

Inclusion Criteria:

  • high-grade osteosarcoma (conventional and non-conventional)
  • parosteal, periosteal or extraosseous osteosarcoma
  • low grade central osteosarcoma
  • (osseous) Undifferentiated pleomorphic sarcoma (UPS)
  • (osseous) leiomyosarcoma
  • (osseous) dedifferentiated chondrosarcoma
  • (osseous) mesenchymal chondrosarcoma
  • (osseous) fibrosarcoma
  • (osseous) angiosarcoma
  • informed consent

Exclusion Criteria:

  • no informed consent

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data Collection
Time Frame: 20 years (There will be continous subgroup analyses through study completion.)
Aims of the registry are the collection of clinical data to gain further insights about diagnosis, treatment, prognosis and risk factors of osteosarcoma and biologically related bone tumors.
20 years (There will be continous subgroup analyses through study completion.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reference Diagnostics
Time Frame: 20 years (Recruitment period)
Aim of the registry is to give the frame for reference diagnostics.
20 years (Recruitment period)
Collection of biologic samples.
Time Frame: 20 years (Recruitment period)
Aim of the registry is the collection of biomaterial.
20 years (Recruitment period)

Collaborators and Investigators

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

Sponsor

Klinikum Stuttgart

Collaborators

Klinikum Kassel GmbH (COSS-Biobank)

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 (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

March 1, 2032

Study Completion (Anticipated)

March 1, 2032

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V.1.3 14.03.2022

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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