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Recruiting NCT04758325

The Sarcoma Biology and Outcome Project

Observational Sarcoma Malignant Mesenchymoma Sarcoma of Bone and Connective Tissue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sarcoma, Malignant Mesenchymoma, Sarcoma of Bone and Connective Tissue. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

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.

Primary outcome measures

  • overall survival [Time frame: 5 years]
  • overall survival [Time frame: 10 years]
Secondary outcome measures (1)
  • progression free survival [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 1 center
  • National Center for Tumour Diseases, University Hospital Heidelberg — Heidelberg

Identifiers

NCT: NCT04758325 · TMO1902

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗