The Sarcoma Biology and Outcome Project

Sarcoma Clinical Trial

— SarcBOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758325
• Other study ID #: TMO1902
• Status: Recruiting
• Start date: July 23, 2019
• Est. completion date: December 31, 2032

Study information

• Verified date: August 2023
• Source: University Hospital Heidelberg
• Contact: Richard F. Schlenk, Prof.Dr.med
• Phone: +49 6221 56 6228
• Email: richard.schlenk[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2032
• Est. primary completion date: July 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Mesenchymoma
• Sarcoma
• Sarcoma of Bone and Connective Tissue

Locations

Country	Name	City	State
Germany	National Center for Tumour Diseases, University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Richard F Schlenk

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Core questionnaire QLQ-C30	Standardized Quality of Life Assessment, Higher values are better	5 years
Other	Fatigue module QLQ-FA12	Standardized Quality of Fatigue, Higher values are worse	5 years
Other	PHQ-4 (anxiety and depression)	Standardized Quality of anxiety and depression, Higher values are worse	5 years
Other	FACT-cog (cognitive function)	Standardized Quality of cognitive function, Higher values are better	5 years
Other	DASH	Disability of the arm, shoulder and hand, lower values are better	5 years
Other	EFAS	European foot and ankle society, higher values are better	5 years
Other	OKS	Oxford knee score function and pain questionnaire after total knee replacement surgery, (TKR), higher values are better	5 years
Other	MSTS	Musculoskeletal tumor society score, higher values are better	5 Years
Other	ODI	Oswestry back pain disability questionnaire after spinal surgery, lower values are better	5 Years
Other	OHS	Oxford hip score - Function and pain questionnaire after hip replacement surgery, higher values are better	5 years
Other	PSQI	Pittsburgh Sleep Quality Index, Higher values are worse	5 years
Other	Sociodemographics	Sociodemographic data	Baseline only
Primary	overall survival	The length of time from the date of diagnosis disease, that patients diagnosed with are still alive	5 years
Primary	overall survival	The length of time from the date of diagnosis disease, that patients diagnosed	10 years
Secondary	progression free survival	length of time during and after treatment, that a Patient lives with the disease without getting worse	5 years

External Links

•   official website of SarcBOP