The Sarcoma Biology and Outcome Project

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Adolescent and Adult Patients With Soft-tissue and Bone Sarcoma

Conditions
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Sarcoma, Malignant Mesenchymoma, Sarcoma of Bone and Connective Tissue

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: • Severe neurological or psychiatric disorder interfering with the ability to give written informed consent

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | The length of time from the date of diagnosis disease, that patients diagnosed with are still alive | 5 years | 
| overall survival | The length of time from the date of diagnosis disease, that patients diagnosed | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival | length of time during and after treatment, that a Patient lives with the disease without getting worse | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rare disease, database, treatment, research, molecular diagnostic, translational approach, interdisciplinary approach