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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Mario Leitao, MD
leitaom@mskcc.org
212-639-3987
Backup
Vance Broach, MD
212-639-6876
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2026-02
Participants
Target number of participants: 1026
Treatments
Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)
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) alone
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov