The Sarcoma Biology and Outcome Project

NCT04758325 | Recruiting DMC

• 1 other identifier: TMO1902
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Malignant Mesenchymoma; Sarcoma of Bone and Connective Tissue

Keywords

rare disease; database; treatment; research; molecular diagnostic; translational approach; interdisciplinary approach

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• progression free survival

  5 years

Other Outcomes (12)

• Core questionnaire QLQ-C30

  5 years

• Fatigue module QLQ-FA12

  5 years

• PHQ-4 (anxiety and depression)

  5 years

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Soft-tissue and Bone Sarcoma

You may qualify if:

• 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

You may not qualify if:

• Severe neurological or psychiatric disorder interfering with the ability to give written informed consent

Sponsors & Collaborators

• Prof. Dr. Richard F Schlenk: lead

Study Sites (1)

National Center for Tumour Diseases, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Links

• official website of SarcBOP

MeSH Terms

Conditions

Sarcoma; Malignant mesenchymal tumor; Osteosarcoma; Rare Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard F. Schlenk, Prof.Dr.med

  National Center for Tumour Disease

  PRINCIPAL INVESTIGATOR

• Christoph E. Heilig, Dr. med.

  National Center for Tumour Disease

  STUDY DIRECTOR

• Stefan Fröhling, Prof. Dr.

  National Center for Tumour Disease

  STUDY DIRECTOR

Central Study Contacts

Richard F. Schlenk, Prof.Dr.med

CONTACT

+49 6221 56 6228; richard.schlenk@med.uni-heidelberg.de

SarcBOP Team

CONTACT

sarcbop@nct-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of NCT trials center and Clinical Trials

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 17, 2021
• Study Start: July 23, 2019
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

DE (1)