OsteosarcomaCOSS-RegistryNCT05515068
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
An observational study of Osteosarcoma and Bone Tumor, run by Klinikum Stuttgart.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteosarcoma, Bone Tumor, Bone Sarcoma
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Mar 2032
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients irrespective of gender, age and tumour location
Who may be able to join
- 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
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- (osseous) mesenchymal chondrosarcoma
- (osseous) fibrosarcoma
- (osseous) angiosarcoma
- informed consent
Who cannot join
- no informed consent
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Osteosarcoma, Bone Tumor, Bone Sarcoma, High Grade Sarcoma, Osteoblastic Osteosarcoma, Chondroblastic Osteosarcoma
- Medical subject headings
- Osteosarcoma, Bone Neoplasms, Histiocytoma, Malignant Fibrous, Osteosarcoma, Juxtacortical
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years (There will be continous subgroup analyses through study completion.)
Secondary outcomes (2)
Reference Diagnostics
Aim of the registry is to give the frame for reference diagnostics.
Measured: 20 years (Recruitment period)
Collection of biologic samples.
Aim of the registry is the collection of biomaterial.
Measured: 20 years (Recruitment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Klinikum Stuttgart
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Kassel GmbH (COSS-Biobank)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515068
- Sponsor's protocol ID
- V.1.3 14.03.2022
- Acronym
- COSS-Registry
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas (COSS-Registry)
- ClinicalTrials.gov ID
- NCT05515068
- Acronym / sponsor ID
- COSS-Registry / V.1.3 14.03.2022
- Conditions
- Osteosarcoma, Bone Tumor, Bone Sarcoma, High Grade Sarcoma, Osteoblastic Osteosarcoma, Chondroblastic Osteosarcoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Klinikum StuttgartUniversity, hospital or other
- Collaborators
- Klinikum Kassel GmbH (COSS-Biobank)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients irrespective of gender, age and tumour location
Key inclusion criteria (10 listed)
- high-grade osteosarcoma (conventional and non-conventional)
- parosteal, periosteal or extraosseous osteosarcoma
- low grade central osteosarcoma
- (osseous) Undifferentiated pleomorphic sarcoma (UPS)
- (osseous) leiomyosarcoma
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Reference Diagnostics
Time frame: 20 years (Recruitment period)
Collection of biologic samples.
Time frame: 20 years (Recruitment period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma and Bone Tumor, run by Klinikum Stuttgart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection (time frame: 20 years (There will be continous subgroup analyses through study completion.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.