Retroperıtoneal Soft-Tıssue Sarcomas
Primary Purpose
Retroperitoneal Sarcoma, Margin, Tumor-Free
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retroperitoneal mass excision
Sponsored by
About this trial
This is an interventional other trial for Retroperitoneal Sarcoma focused on measuring Soft tissue sarcoma, Surgery, Multidisciplinary Sarcoma Team
Eligibility Criteria
Inclusion Criteria:
- Patients operated with the diagnosis of intra-abdominal mass
- patients diagnosed with pathological sarcoma subclasses
Exclusion Criteria:
- Patients younger than 18 years
- Visceral organ-origin sarcomas
- extremity sarcomas
- GIST
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Margin, Tumor-Free
Arm Description
Outcomes
Primary Outcome Measures
Clean margin wide resection
effect of clean surgical margin on recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT05044624
First Posted
September 2, 2021
Last Updated
September 9, 2021
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT05044624
Brief Title
Retroperıtoneal Soft-Tıssue Sarcomas
Official Title
Retroperıtoneal Soft-Tıssue Sarcomas: Retrospectıve Clınıcal Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
: Soft Tissue Sarcomas are rare mesenchymal tumors with many subtypes. Clean margin-wide resection is recommended for treatment. The guidelines recommend that sarcoma treatments be carried out in sarcoma centers. In this study, the location, histopathological features, clinical and demographic features, recurrence, and prognosis of retroperitoneal sarcomas were investigated.
Detailed Description
The demographic, histopathological, and immunohistochemical data of the patients who were operated on with the diagnosis of intraabdominal mass at Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital from March 2016 to December 2020 were retrospectively evaluated. Ethical approval was obtained from Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital Ethics Committee.
Patients diagnosed with pathological sarcoma subclass were included in the study. Patients younger than 18 years were excluded from the study. Visceral organ-origin sarcomas and extremity sarcomas were also excluded from the study. GIST's were included in sarcoma subtypes by WHO in 2013. However, they were not included in the study due to their solid organ origin.
The data of 18 patients' whore remained after the exclusion criteria were analyzed retrospectively. Pathology samples of the patients were re-examined by a single pathologist.
The demographic analysis was used for statistics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retroperitoneal Sarcoma, Margin, Tumor-Free
Keywords
Soft tissue sarcoma, Surgery, Multidisciplinary Sarcoma Team
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Margin, Tumor-Free
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
retroperitoneal mass excision
Intervention Description
retroperitoneal mass excision
Primary Outcome Measure Information:
Title
Clean margin wide resection
Description
effect of clean surgical margin on recurrence
Time Frame
63 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients operated with the diagnosis of intra-abdominal mass
patients diagnosed with pathological sarcoma subclasses
Exclusion Criteria:
Patients younger than 18 years
Visceral organ-origin sarcomas
extremity sarcomas
GIST
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Retroperıtoneal Soft-Tıssue Sarcomas
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