SarcomaSarcBOPNCT04758325
The Sarcoma Biology and Outcome Project
An observational study of Sarcoma and Malignant Mesenchymoma, run by Prof. Dr. Richard F Schlenk at 1 site in Germany.
Trial summary
SarcBOP - An interdisciplinary and translational registry SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sarcoma, Malignant Mesenchymoma, Sarcoma of Bone and Connective Tissue
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jul 2019to 31 Dec 2032
- How long will I take part?
- 10 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Soft-tissue and Bone Sarcoma
Who may be able to join
- Suspected or proven diagnosis of soft-tissue or bone sarcoma (STBS)
- Age ≥12 years
- Ability to understand nature and individual consequences of the registry
- Written informed consent
- Subjects who are physically or mentally capable of giving consent
Who cannot join
- Severe neurological or psychiatric disorder interfering with the ability to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
SarcBOP Team contact
Germany1 site, 1 recruiting
- Recruiting
National Center for Tumour Diseases, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Editha Gnutzmann, M.A., +49 6221 5636235, editha.gnutzmann@med.uni-heidelberg.de
SarcBOP Team, sarcbop@nct-heidelberg.de
About this study
Official title: A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Adolescent and Adult Patients With Soft-tissue and Bone Sarcoma
SarcBOP - An interdisciplinary and translational registry
SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical, pathologic, and radiologic information, multi-layered molecular data, and patient-reported outcomes, combined with a dedicated biobank for tissue samples and liquid biopsies. As the study integrates seamlessly with the clinical activities of the Heidelberg Sarcoma Center, the Molecular Diagnostics Program of NCT Heidelberg, including the NCT/DKTK MASTER Program, and with the NCT Trial Center, including the PMO Clinical Trials Program, SarcBOP will generate a comprehensive and continuously growing resource for clinicians, researchers, and, finally, patients.
Read the detailed description
The following data are collected and stored:
- Demographics
- Comorbidities
- Clinical characteristics at diagnosis, relapse and progression
- Radiologic images
- Histological images
- Treatments including DRG and OPS data, including detailed information on surgical, radiation, and medical therapy as well as treatment relevant follow-up data
- Longitudinal disease assessments
- Clinical outcome
- Genomic, transcriptomic, epigenomic and proteomic data
- Patient reported outcomes
Furthermore, biological samples are collected and processed by the Sample Processing Laboratory of the Heidelberg Center for Personalized Oncology and the NCT Biobank.
- Keywords
- rare disease, database, treatment, research, molecular diagnostic, translational approach, interdisciplinary approach
- Medical subject headings
- Sarcoma, Malignant mesenchymal tumor, Osteosarcoma, Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The length of time from the date of diagnosis disease, that patients diagnosed with are still alive
Measured: 5 years
overall survival
The length of time from the date of diagnosis disease, that patients diagnosed
Measured: 10 years
Secondary outcomes (1)
progression free survival
length of time during and after treatment, that a Patient lives with the disease without getting worse
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start23 Jul 2019
- Primary completionJul 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Richard F Schlenk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Richard F Schlenk, University Hospital Heidelberg
- Investigators
- Richard F. Schlenk, Prof.Dr.med, Principal investigator, National Center for Tumour DiseaseChristoph E. Heilig, Dr. med., Study director, National Center for Tumour DiseaseStefan Fröhling, Prof. Dr., Study director, National Center for Tumour Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758325
- Sponsor's protocol ID
- TMO1902
- Acronym
- SarcBOP
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Adolescent and Adult Patients With Soft-tissue and Bone Sarcoma
- ClinicalTrials.gov ID
- NCT04758325
- Acronym / sponsor ID
- SarcBOP / TMO1902
- Keywords
- rare disease, database, treatment, research, molecular diagnostic, translational approach, interdisciplinary approach
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Prof. Dr. Richard F SchlenkUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 17 Feb 2021 (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.
SarcBOP - An interdisciplinary and translational registry
SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical, pathologic, and radiologic information, multi-layered molecular data, and patient-reported outcomes, combined with a dedicated biobank for tissue samples and liquid biopsies. As the study integrates seamlessly with the clinical activities of the Heidelberg Sarcoma Center, the Molecular Diagnostics Program of NCT Heidelberg, including the NCT/DKTK MASTER Program, and with the NCT Trial Center, including the PMO Clinical Trials Program, SarcBOP will generate a comprehensive and continuously growing resource for clinicians, researchers, and, finally, patients.
Detailed description
The following data are collected and stored:
- Demographics
- Comorbidities
- Clinical characteristics at diagnosis, relapse and progression
- Radiologic images
- Histological images
- Treatments including DRG and OPS data, including detailed information on surgical, radiation, and medical therapy as well as treatment relevant follow-up data
- Longitudinal disease assessments
- Clinical outcome
- Genomic, transcriptomic, epigenomic and proteomic data
- Patient reported outcomes
Furthermore, biological samples are collected and processed by the Sample Processing Laboratory of the Heidelberg Center for Personalized Oncology and the NCT Biobank.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Soft-tissue and Bone Sarcoma
Key inclusion criteria (5 listed)
- Suspected or proven diagnosis of soft-tissue or bone sarcoma (STBS)
- Age ≥12 years
- Ability to understand nature and individual consequences of the registry
- Written informed consent
- Subjects who are physically or mentally capable of giving consent
Key exclusion criteria (1 listed)
- Severe neurological or psychiatric disorder interfering with the ability to give written 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
overall survival
Time frame: 5 years
The length of time from the date of diagnosis disease, that patients diagnosed with are still alive
overall survival
Time frame: 10 years
The length of time from the date of diagnosis disease, that patients diagnosed
1 secondary outcome
progression free survival
Time frame: 5 years
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 Mar 2025.
- official website of SarcBOPLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
SarcBOP Team contact
Richard F. Schlenk, Prof.Dr.med principal investigator
National Center for Tumour Disease
Christoph E. Heilig, Dr. med. study director
National Center for Tumour Disease
Stefan Fröhling, Prof. Dr. study director
National Center for Tumour Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Malignant Mesenchymoma, run by Prof. Dr. Richard F Schlenk at 1 site in Germany.
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 5 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Richard F. Schlenk, Prof.Dr.med (+49 6221 56 6228, richard.schlenk@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 Mar 2025.