Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758325
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2021-02-04
Brief Title:
The Sarcoma Biology and Outcome Project
Sponsor:
Prof Dr Richard F Schlenk
Organization:
University Hospital Heidelberg
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SarcBOP
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 NCTDKTK 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
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 NCTDKTK 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None