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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Specificity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
研究概览
简要总结
Lymphedema is a chronic, debilitating disorder characterized by abnormal tissue swelling, adipose deposition and tissue fibrosis, resulting from disruption, blockage, or genetic abnormalities of the lymphatic system. Secondary lymphedema is an acquired lymphedema due to trauma, surgery, radiotherapy or infection among others resulting in a decreased transport capacity of the lymphatic system. This can be combined with an additional load on the lymphatic system due to obesity, venous hypertension or a wound, among others. Advances in oncologic treatment have led to an ever-increasing number of cancer survivors over time. As a result, morbidities related to this treatment (such as secondary lymphedema) are likely to increase too.
Risk factors for the development of LLL after treatment for (gynaecological) cancer are: pelvic and para-aortic lymphadenectomy, the number of pelvic lymph nodes removed, adjuvant radiotherapy, adjuvant chemotherapy, increasing BMI/ BMI ≥25 kg/m², lymphocyst formation, increasing age, increasing time since surgery and insufficient physical activity level.
To the investigators knowledge, no evidence exists regarding which (combination of) measuring methods are most sensitive to detect early lymphedema at the lower limbs after the treatment of cancer. Thresholds for identifying subclinical edema on one or both lower limbs are lacking.
Therefore the investigators want to develop a screening set for patients at risk for developing LLL. Which measurement method (and which criterion) shows the best diagnostic accuracy in screening patients at risk for LLL after cancer treatment? And: What is the added value of combining different measurement methods in terms of diagnostic accuracy?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Specificity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
时间窗: up to 12 months post-surgery
Specificity of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery
Diagnostic accuracy of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
时间窗: up to 12 months post-surgery
Diagnostic accuracy of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery
Sensitivity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
时间窗: up to 12 months post-surgery
Sensitivity of reliable and clinical feasible measurement methods (resulted from aim 1: NCT05269264) regarding the screening of patients at risk for developing unilateral or bilateral LLL at 6 weeks, 6, and 12 months post-surgery
次要结局
- Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 12 months post-surgery.(12 months post-surgery)
- Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 6 weeks post- surgery(6 weeks post- surgery)
- Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 12 months post- surgery(12 months post- surgery)
- Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(at 6 weeks post-surgery)
- Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Number of positive lymph nodes' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Number of positive lymph nodes' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'Postoperative complications' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'Postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'Type of lymph node dissection' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Type of lymph node dissection' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Prognostic value of 'Number of lymph nodes removed' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Number of lymph nodes removed' for the development of bilateral lower limb lymphoedema at 12 months post-surgery(12 months post-surgery)
- Incidence rate of unilateral and bilateral LLL at 6 weeks post-surgery(6 weeks post-surgery)
- Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery(6 weeks post-surgery)
- Incidence rate of unilateral and bilateral LLL at 6 months post-surgery(6 months post-surgery)
- Incidence rate of unilateral and bilateral LLL at 12 months post-surgery(12 months post-surgery)
研究者
Tessa De Vrieze
Post-doctoral research fellow and physiotherapist, PhD in Biomedical Sciences (Catholic University of Leuven) and Medical Sciences (University of Antwerp)
KU Leuven