NCT05515068

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
71mo left

Started Sep 2022

Longer than P75 for all trials

Status
not yet 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%
Sep 2022Mar 2032

First Submitted

Initial submission to the registry

August 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

9.5 years

First QC Date

August 16, 2022

Last Update Submit

August 24, 2022

Conditions

OsteosarcomaBone TumorBone SarcomaHigh Grade SarcomaOsteoblastic OsteosarcomaChondroblastic OsteosarcomaFibroblastic OsteosarcomaConventional OsteosarcomaConventional Central Osteosarcoma of BoneLow Grade Central OsteosarcomaOsseous SarcomaOsseous TumorSmall Cell OsteosarcomaTelangiectatic OsteosarcomaUndifferentiated Pleomorphic SarcomaParosteal OsteosarcomaPeriosteal OsteosarcomaExtraskeletal OsteosarcomaRecurrent OsteosarcomaHigh Grade Surface OsteosarcomaOsseous AngiosarcomaOsseous FibrosarcomaOsseous LeiomyosarcomaOsseous Dedifferentiated ChondrosarcomaOsseous Mesenchymal ChondrosarcomaClear Cell Osteosarcoma

Outcome Measures

Primary Outcomes (1)

  • Data Collection

    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 Outcomes (2)

  • Reference Diagnostics

    20 years (Recruitment period)

  • Collection of biologic samples.

    20 years (Recruitment period)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients irrespective of gender, age and tumour location

You may qualify if:

  • 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

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and blood

MeSH Terms

Conditions

OsteosarcomaBone NeoplasmsHistiocytoma, Malignant FibrousOsteosarcoma, Juxtacortical

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaNeoplasms by SiteBone DiseasesMusculoskeletal DiseasesHistiocytomaNeoplasms, Fibrous Tissue

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 25, 2022

Study Start

September 1, 2022

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Last Updated

August 25, 2022

Record last verified: 2022-08