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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
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Retroperitoneal Sarcoma focused on measuring Soft tissue sarcoma, Surgery, Multidisciplinary Sarcoma Team

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 2, 2021
    Last Updated
    September 9, 2021
    Sponsor
    Istanbul Medeniyet University
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    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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