The Sarcoma Biology and Outcome Project

Recruiting

• Conditions: Malignant Mesenchymoma; Sarcoma; Sarcoma of Bone and Connective Tissue

• Registration Number: NCT04758325
• Lead Sponsor: Prof. Dr. Richard F Schlenk

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.

Study Timeline

• Study Start: 2019-07-23
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2030-07
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	10 years	The length of time from the date of diagnosis disease, that patients diagnosed

Secondary Outcome Measures

Name	Time	Method
progression free survival	5 years	length of time during and after treatment, that a Patient lives with the disease without getting worse

Trial Locations

Locations (1)

National Center for Tumour Diseases, University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany