Clinical trial NCT05421377: Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Limb Lymphedema
Keywords: screening
urogenital cancer
gynaecological cancer
skin cancer
lymph node dissection
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2022-06-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients at risk for LLL (i.e. patients undergoing pelvic/inguinal/para-aortic lymph node dissection for uro-genital, gynaecological or skin cancer) will be included from pre-surgery up to 12 months post-surgery

Brief summary: 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?


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

Primary outcomes:
measure: Sensitivity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
timeFrame: up to 12 months post-surgery
measure: Specificity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
timeFrame: up to 12 months post-surgery
measure: Diagnostic accuracy of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
timeFrame: up to 12 months post-surgery
Secondary outcomes:
measure: Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 12 months post-surgery.
timeFrame: 12 months post-surgery
measure: Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 6 weeks post- surgery
timeFrame: 6 weeks post- surgery
measure: Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 12 months post- surgery
timeFrame: 12 months post- surgery
measure: Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: at 6 weeks post-surgery
measure: Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Number of positive lymph nodes' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Number of positive lymph nodes' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Postoperative complications' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Type of lymph node dissection' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Type of lymph node dissection' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Number of lymph nodes removed' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Number of lymph nodes removed' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
timeFrame: 12 months post-surgery
measure: Incidence rate of unilateral and bilateral LLL at 6 weeks post-surgery
timeFrame: 6 weeks post-surgery
measure: Incidence rate of unilateral and bilateral LLL at 6 months post-surgery
timeFrame: 6 months post-surgery
measure: Incidence rate of unilateral and bilateral LLL at 12 months post-surgery
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals of Leuven
Study officials:
affiliation: KU Leuven
name: Tessa De Vrieze, Dr.
role: PRINCIPAL_INVESTIGATOR
References: