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NCT05255393 Clinical Trial

Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer

Cervical Cancer Clinical Trial

Official title:
RELEVANT Prevalence of Patient-Reported Lymphedema Following Surgical Management of Cervical or Vulvar Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05255393
Other study ID # 22-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date February 2025

Study information
Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact Mario Leitao, MD
Phone 212-639-3987
Email leitaom@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure. Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.

Recruitment information / eligibility
Status Recruiting
Enrollment 1026
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage squamous cell carcinoma of the vulva. °Early stage: Stage 1-2 - Underwent primary surgery at our institution between January 2006 and January 2022. - Alive at the time of study activation - English comprehension - Capable of providing informed consent Exclusion Criteria: - Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic. The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. The EORTC Quality of Life - Cervical Cancer Module.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of patient-reported lower extremity lymphedema Prevalence will be measured using the 13-item questionnaire as reported by the patient. 1 year
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