Clinical trial NCT04758325: The Sarcoma Biology and Outcome Project
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Malignant Mesenchymoma
Sarcoma of Bone and Connective Tissue
Keywords: rare disease
database
treatment
research
molecular diagnostic
translational approach
interdisciplinary approach
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Soft-tissue and Bone Sarcoma

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.

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.

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

Primary outcomes:
measure: overall survival
timeFrame: 5 years
measure: overall survival
timeFrame: 10 years
Secondary outcomes:
measure: progression free survival
timeFrame: 5 years
Other outcomes:
measure: Core questionnaire QLQ-C30
timeFrame: 5 years
measure: Fatigue module QLQ-FA12
timeFrame: 5 years
measure: PHQ-4 (anxiety and depression)
timeFrame: 5 years
measure: FACT-cog (cognitive function)
timeFrame: 5 years
measure: DASH
timeFrame: 5 years
measure: EFAS
timeFrame: 5 years
measure: OKS
timeFrame: 5 years
measure: MSTS
timeFrame: 5 Years
measure: ODI
timeFrame: 5 Years
measure: OHS
timeFrame: 5 years
measure: PSQI
timeFrame: 5 years
measure: Sociodemographics
timeFrame: Baseline only
Locations:
city: Heidelberg
country: Germany
facility: National Center for Tumour Diseases, University Hospital Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: National Center for Tumour Disease
name: Richard F. Schlenk, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Tumour Disease
name: Christoph E. Heilig, Dr. med.
role: STUDY_DIRECTOR
affiliation: National Center for Tumour Disease
name: Stefan Fröhling, Prof. Dr.
role: STUDY_DIRECTOR
References: