COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-15
Study Completion:2025-11-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05255393

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile.
  2. * Underwent primary surgery at our institution between January 2006 and January 2022.
  3. * Alive at the time of study activation
  4. * English comprehension
  5. * Capable of providing informed consent
  1. * Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis

Contacts and Locations

Principal Investigator

Mario Leitao, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Mario Leitao, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15
Study Completion Date2025-11-19

Study Record Updates

Study Start Date2022-02-15
Study Completion Date2025-11-19

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Cervical Cancer
  • Vulvar Cancer