Survey on lymphedema risk after lymph node biopsy in cervical or vulvar cancer patients
RELEVANT Prevalence of Patient-Reported Lymphedema Following Surgical Management of Cervical or Vulvar Cancer
This study is trying to find out which patients with early-stage cervical or vulvar cancer are at risk of developing swelling in their legs after having a lymph node biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1026 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05255393 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather information from patients who have undergone sentinel lymph node biopsy for early-stage cervical or vulvar cancer. By utilizing questionnaires, the researchers will identify individuals at risk of developing lower extremity lymphedema following the procedure. The goal is to enhance the quality and accuracy of information provided to patients regarding their risk of lymphedema after surgery. No treatments or investigational procedures will be conducted as part of this study.
Who should consider this trial
Good fit: Ideal candidates are individuals with newly diagnosed early-stage cervical or vulvar cancer who have undergone primary surgery at the institution.
Not a fit: Patients with documented metastatic disease at the time of initial diagnosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for patients undergoing sentinel lymph node biopsy.
How similar studies have performed: While this study focuses on a specific patient population, similar observational studies have successfully identified risk factors for lymphedema in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mario Leitao, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Mario Leitao, MD
- Email: leitaom@mskcc.org
- Phone: 212-639-3987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.