Malignant Mesenchymoma, Sarcoma, Sarcoma of Bone and Connective Tissue
Conditions
Keywords
rare disease, database, treatment, research, molecular diagnostic, translational approach, interdisciplinary approach
Brief 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, 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.
Interventions
None listed
Sponsors
Prof. Dr. Richard F Schlenk
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | The length of time from the date of diagnosis disease, that patients diagnosed with are still alive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 5 years | length of time during and after treatment, that a Patient lives with the disease without getting worse |
Other
| Measure | Time frame | Description |
|---|---|---|
| PHQ-4 (anxiety and depression) | 5 years | Standardized Quality of anxiety and depression, Higher values are worse |
| FACT-cog (cognitive function) | 5 years | Standardized Quality of cognitive function, Higher values are better |
| DASH | 5 years | Disability of the arm, shoulder and hand, lower values are better |
| EFAS | 5 years | European foot and ankle society, higher values are better |
| OKS | 5 years | Oxford knee score function and pain questionnaire after total knee replacement surgery, (TKR), higher values are better |
| Core questionnaire QLQ-C30 | 5 years | Standardized Quality of Life Assessment, Higher values are better |
| ODI | 5 Years | Oswestry back pain disability questionnaire after spinal surgery, lower values are better |
| OHS | 5 years | Oxford hip score - Function and pain questionnaire after hip replacement surgery, higher values are better |
| PSQI | 5 years | Pittsburgh Sleep Quality Index, Higher values are worse |
| Sociodemographics | Baseline only | Sociodemographic data |
| MSTS | 5 Years | Musculoskeletal tumor society score, higher values are better |
| Fatigue module QLQ-FA12 | 5 years | Standardized Quality of Fatigue, Higher values are worse |
Countries
Germany
Contacts
Primary ContactRichard F. Schlenk, Prof.Dr.med
Backup ContactSarcBOP Team
Outcome results
None listed