The Sarcoma Biology and Outcome Project (SarcBOP)

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Richard F. Schlenk, Prof.Dr.med; Phone Number: +49 6221 56 6228; Email: richard.schlenk@med.uni-heidelberg.de
• Study Contact Backup: Name: SarcBOP Team; Email: sarcbop@nct-heidelberg.de

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69120
      • Recruiting
      • National Center for Tumour Diseases, University Hospital Heidelberg
      • Contact: SarcBOP Team; Email: sarcbop@nct-heidelberg.de
      • Contact: Editha Gnutzmann, M.A.; Phone Number: +49 6221 5636235; Email: editha.gnutzmann@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Soft-tissue and Bone Sarcoma

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core questionnaire QLQ-C30	Standardized Quality of Life Assessment, Higher values are better	5 years
Fatigue module QLQ-FA12	Standardized Quality of Fatigue, Higher values are worse	5 years
PHQ-4 (anxiety and depression)	Standardized Quality of anxiety and depression, Higher values are worse	5 years
FACT-cog (cognitive function)	Standardized Quality of cognitive function, Higher values are better	5 years
DASH	Disability of the arm, shoulder and hand, lower values are better	5 years
EFAS	European foot and ankle society, higher values are better	5 years
OKS	Oxford knee score function and pain questionnaire after total knee replacement surgery, (TKR), higher values are better	5 years
MSTS	Musculoskeletal tumor society score, higher values are better	5 Years
ODI	Oswestry back pain disability questionnaire after spinal surgery, lower values are better	5 Years
OHS	Oxford hip score - Function and pain questionnaire after hip replacement surgery, higher values are better	5 years
PSQI	Pittsburgh Sleep Quality Index, Higher values are worse	5 years
Sociodemographics	Sociodemographic data	Baseline only

Collaborators and Investigators

• Sponsor: Prof. Dr. Richard F Schlenk
• Investigators: Principal Investigator: Richard F. Schlenk, Prof.Dr.med, National Center for Tumour Disease; Study Director: Christoph E. Heilig, Dr. med., National Center for Tumour Disease; Study Director: Stefan Fröhling, Prof. Dr., National Center for Tumour Disease

Publications and helpful links

Helpful Links

• official website of SarcBOP

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: treatment; rare disease; database; research; molecular diagnostic; translational approach; interdisciplinary approach
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Sarcoma; Mesenchymoma
• Other Study ID Numbers: TMO1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No