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

Recruiting

• Conditions: Cervical Cancer; Vulvar Cancer
• Interventions: Other: Questionnaires

• Registration Number: NCT05255393
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1026

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard lymphadenectomy(LND) alone	Questionnaires	Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires. No other interventions are planned.
Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)	Questionnaires	Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires. No other interventions are planned.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States