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The Sarcoma Biology and Outcome Project (SarcBOP)

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ClinicalTrials.gov Identifier: NCT04758325
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Richard F Schlenk, University Hospital Heidelberg

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Sarcoma Malignant Mesenchymoma Sarcoma of Bone and Connective Tissue

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients With Soft-tissue and Bone Sarcoma
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 2030
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Soft-tissue and Bone Sarcoma
Criteria

Inclusion Criteria:

  • Suspected or proven diagnosis of soft-tissue or bone sarcoma (STBS)
  • Age ≥18 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758325


Contacts
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Contact: Richard F. Schlenk, Prof.Dr.med +49 6221 56 6228 richard.schlenk@med.uni-heidelberg.de
Contact: SarcBOP Team sarcbop@nct-heidelberg.de

Locations
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Germany
National Center for Tumour Diseases, University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Editha Gnutzmann, M.A.    +49 6221 5636235    editha.gnutzmann@med.uni-heidelberg.de   
Contact: SarcBOP Team       sarcbop@nct-heidelberg.de   
Sponsors and Collaborators
Prof. Dr. Richard F Schlenk
Investigators
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Principal Investigator: Richard F. Schlenk, Prof.Dr.med National Center for Tumour Disease
Study Director: Christoph E. Heilig, Dr. med. National Center for Tumour Disease
Study Director: Stefan Fröhling, Prof. Dr. National Center for Tumour Disease
More Information
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Additional Information:

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Responsible Party: Prof. Dr. Richard F Schlenk, Head of NCT trials center and Clinical Trials, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04758325    
Other Study ID Numbers: TMO1902
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Richard F Schlenk, University Hospital Heidelberg:
rare disease
database
treatment
research
 molecular diagnostic
translational approach
interdisciplinary approach
Additional relevant MeSH terms:
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Sarcoma
Mesenchymoma
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed