SarcBOP: The Sarcoma Biology and Outcome Project

Sponsor

Prof. Dr. Richard F Schlenk (Other)

Overall Status

Recruiting

CT.gov ID

NCT04758325

Collaborator

(none)

3,000

Enrollment

Location

161.3

Anticipated Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 23, 2019

Anticipated Primary Completion Date :

Jul 1, 2030

Anticipated Study Completion Date :

Dec 31, 2032

Outcome Measures

Primary Outcome Measures

overall survival [5 years]
The length of time from the date of diagnosis disease, that patients diagnosed with are still alive
overall survival [10 years]
The length of time from the date of diagnosis disease, that patients diagnosed

Secondary Outcome Measures

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

Other Outcome Measures

Core questionnaire QLQ-C30 [5 years]
Standardized Quality of Life Assessment, Higher values are better
Fatigue module QLQ-FA12 [5 years]
Standardized Quality of Fatigue, Higher values are worse
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
MSTS [5 Years]
Musculoskeletal tumor society score, 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Suspected or proven diagnosis of soft-tissue or bone sarcoma (STBS)
Age ≥18 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center for Tumour Diseases, University Hospital Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120

Sponsors and Collaborators

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