NCT05255393

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 111 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer
• Vulvar Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-15
• Primary completion: 2025-11-19
• Completion: 2025-11-19
• First posted: 2022-02-24
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States