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Identification of Surgical Management of Lymph Node Basins and Surgical Practice Patterns Among Sarcoma Surgeons

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ClinicalTrials.gov Identifier: NCT04553744
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This study investigates the surgical management of lymph node basins for extremity and trunk soft tissue sarcoma (ETSTS) to identify and better understand the surgical practice patterns of sarcoma surgeons. ETSTS has been known to spread to distant locations including lymph nodes, with some subtypes of the disease spreading to lymph nodes more than others. This has led to sarcoma surgeons to treat patients differently from one another, including those with more lymph node involvement. The purpose of this study is to investigate the practice patterns of ETSTS surgeons.

Condition or disease Intervention/treatment
Soft Tissue Sarcoma Lymph Node Cancer Other: Survey Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. Identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).

II. Identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.

III. Identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.

OUTLINE:

Participants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma.

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survey of Extremity and Trunk Sarcoma Surgeons Regarding Surgical Management of Lymph Node Basins
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (survey)
Participants complete an online survey over 5-10 minutes asking how they would manage lymph node basins in the extremity sarcoma.
 Other: Survey Administration
Complete survey


Outcome Measures
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Primary Outcome Measures :
  1. Practice patterns of sarcoma surgeons [ Time Frame: Up to 2 years ]
    Will identify the practice patterns of sarcoma surgeons with respect to management of lymph node basins for extremity and trunk soft tissue sarcomas (ETSTS).

  2. Sentinel lymph node biopsy and/or lymph node dissection for ETSTS [ Time Frame: Up to 2 years ]
    Will identify when surgeons would perform sentinel lymph node biopsy and/or lymph node dissection for ETSTS, and if management differs for high-risk subtypes of sarcoma that are more likely to have nodal metastases.

  3. Differences in practice patterns [ Time Frame: Up to 2 years ]
    Will identify differences in practice patterns between surgical oncologists and orthopedic oncologic surgeons.


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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Practicing surgeons who are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society, and treat extremity and trunk soft tissue sarcomas.
Criteria

Inclusion Criteria:

  • Currently practicing surgeons who treat ETSTS and are members of The Society of Surgical Oncology and Musculoskeletal Tumor Society

Exclusion Criteria:

None

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): NCT04553744


Contacts
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Contact: Christina L Roland 713-792-6940 clroland@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Christina L. Roland    713-792-6940    clroland@mdanderson.org   
Principal Investigator: Christina L. Roland         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christina L Roland M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04553744    
Other Study ID Numbers: 2020-0099
NCI-2020-06478 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0099 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms