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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05255393

Enrollment

111

Registered

2022-02-24

Start date

2022-02-15

Completion date

2025-11-19

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Vulvar Cancer

Keywords

Questionnaire, Sentinel Lymph Node Biopsy, Lymphedema, 22-002

Brief 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.

Interventions

OTHERQuestionnaires

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile. °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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026