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Search / Trial NCT05421377

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2

Launched by KU LEUVEN · Jun 13, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Screening Urogenital Cancer Gynaecological Cancer Skin Cancer Lymph Node Dissection

ClinConnect Summary

This clinical trial is focused on developing a new tool to help identify and diagnose lower limb lymphedema, a condition that causes swelling in the legs due to problems with the lymphatic system. This condition can occur after treatments for certain cancers, particularly in patients who have had surgery or radiation therapy. The researchers want to find the best ways to measure early signs of lymphedema so that patients can receive timely care. They will explore different measurement methods to see which ones work best for detecting this condition in at-risk patients.

To participate in the trial, individuals should be between the ages of 65 and 74 and have been diagnosed with specific types of cancer, such as skin melanoma or gynecological cancer, which will require surgery that involves lymph node removal. Unfortunately, pregnant women and those with certain other health conditions, like severe vein problems or skin infections in the legs, cannot take part in the study. Participants can expect to undergo various tests and measurements to help researchers understand the best ways to screen for lymphedema, ultimately aiming to improve care for future patients.

Gender

ALL

Eligibility 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

About Ku Leuven

KU Leuven, a prestigious research university located in Belgium, is renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, KU Leuven integrates cutting-edge research with clinical practice, facilitating the development of new therapeutic strategies and medical technologies. The institution's robust infrastructure and expertise in various fields, including biotechnology, pharmacology, and public health, position it as a leader in conducting high-quality clinical research that adheres to rigorous ethical standards and regulatory requirements. Through its clinical trials, KU Leuven aims to contribute significantly to the global biomedical landscape and enhance health outcomes for diverse populations.

Locations

Leuven, , Belgium

Patients applied

0 patients applied

Trial Officials

Tessa De Vrieze, Dr.

Principal Investigator

KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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