The Sarcoma Biology and Outcome Project

NCT ID: NCT04758325

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-23

Study Completion Date

2032-12-31

Brief Summary

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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

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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.

Conditions

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Sarcoma Malignant Mesenchymoma Sarcoma of Bone and Connective Tissue

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Richard F Schlenk

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Richard F Schlenk

Head of NCT trials center and Clinical Trials

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Richard F. Schlenk, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumour Disease

Christoph E. Heilig, Dr. med.

Role: STUDY_DIRECTOR

National Center for Tumour Disease

Stefan Fröhling, Prof. Dr.

Role: STUDY_DIRECTOR

National Center for Tumour Disease

Locations

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National Center for Tumour Diseases, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Richard F. Schlenk, Prof.Dr.med

Role: CONTACT

+49 6221 56 6228

SarcBOP Team

Role: CONTACT

Facility Contacts

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Editha Gnutzmann, M.A.

Role: primary

+49 6221 5636235

SarcBOP Team

Role: backup

Related Links

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http://www.nct-heidelberg.de/sarcbop

official website of SarcBOP

Other Identifiers

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TMO1902

Identifier Type: -

Identifier Source: org_study_id

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