Tool for screening and diagnosing lower limb lymphedema in cancer patients
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Development of a Screening Set for Patients at Risk for Developing LLL
This study is trying to create a new tool to help doctors spot and diagnose lower limb lymphedema in cancer patients, especially those who have had certain types of cancer surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05421377 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a clinical screening, diagnostic, and evaluation tool specifically for patients suffering from lower limb lymphedema, particularly those with a history of skin melanoma, gynecological cancer, or urogenital cancer. The study focuses on patients who are undergoing surgical procedures that may increase their risk of developing lymphedema, such as lymph node dissection. By assessing various risk factors and clinical parameters, the study seeks to improve early detection and management of this chronic condition. The findings could lead to better patient outcomes and quality of life for cancer survivors.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with skin melanoma (stage 3 or higher), gynecological cancer, or urogenital cancer who are scheduled for surgery involving lymph node dissection.
Not a fit: Patients who are pregnant or have chronic venous insufficiency, deep venous thrombosis, or active skin infections on the lower limbs will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly enhance the early detection and management of lower limb lymphedema, improving the quality of life for affected patients.
How similar studies have performed: While there may be studies focusing on lymphedema management, this specific approach to developing a comprehensive screening and diagnostic tool appears to be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of skin melanoma (at the level of the lower limb, at least cancer stage 3), gynecological cancer, uro-genital cancer that will receive surgery (sentinel lymph node biopsy and/or (para-aortic/inguinal/pelvic) lymph node dissection) Exclusion Criteria: * Pregnant participants * Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome * Presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion
Where this trial is running
Leuven
- University Hospitals of Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Tessa De Vrieze, Dr. — KU Leuven
- Study coordinator: Tessa De Vrieze, Dr.
- Email: tessa.devrieze@kuleuven.be
- Phone: 003216345006
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.