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NCT Number: NCT04758325

The Sarcoma Biology and Outcome Project

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.

Recruiting

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Key information

Conditions

Sarcoma Disease Attributes Malignant Mesenchymoma Malignant mesenchymal tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Sarcoma of Bone and Connective Tissue

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Tumour Diseases, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location status: Recruiting

Location contact

Editha Gnutzmann, M.A.

CONTACT

[email protected]

+49 6221 5636235

SarcBOP Team

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: 5 years

    The length of time from the date of diagnosis disease, that patients diagnosed with are still alive

  2. overall survival

    Time frame: 10 years

    The length of time from the date of diagnosis disease, that patients diagnosed

Secondary outcomes

  1. progression free survival

    Time frame: 5 years

    length of time during and after treatment, that a Patient lives with the disease without getting worse

Other outcomes

  1. Core questionnaire QLQ-C30

    Time frame: 5 years

    Standardized Quality of Life Assessment, Higher values are better

  2. Fatigue module QLQ-FA12

    Time frame: 5 years

    Standardized Quality of Fatigue, Higher values are worse

  3. PHQ-4 (anxiety and depression)

    Time frame: 5 years

    Standardized Quality of anxiety and depression, Higher values are worse

  4. FACT-cog (cognitive function)

    Time frame: 5 years

    Standardized Quality of cognitive function, Higher values are better

  5. DASH

    Time frame: 5 years

    Disability of the arm, shoulder and hand, lower values are better

  6. EFAS

    Time frame: 5 years

    European foot and ankle society, higher values are better

  7. OKS

    Time frame: 5 years

    Oxford knee score function and pain questionnaire after total knee replacement surgery, (TKR), higher values are better

  8. MSTS

    Time frame: 5 Years

    Musculoskeletal tumor society score, higher values are better

  9. ODI

    Time frame: 5 Years

    Oswestry back pain disability questionnaire after spinal surgery, lower values are better

  10. OHS

    Time frame: 5 years

    Oxford hip score - Function and pain questionnaire after hip replacement surgery, higher values are better

  11. PSQI

    Time frame: 5 years

    Pittsburgh Sleep Quality Index, Higher values are worse

  12. Sociodemographics

    Time frame: Baseline only

    Sociodemographic data

Study contacts

Contact information is provided by the study sponsor or research team.

Richard F. Schlenk, Prof.Dr.med

CONTACT

[email protected]

+49 6221 56 6228

SarcBOP Team

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Prof. Dr. Richard F Schlenk

Other

Registry information

Official study 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

Acronym: SarcBOP

Important dates

Study start
2019
Primary completion
2030
Study completion
2032
First posted
Feb 17, 2021
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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