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

NCT05421377 | Recruiting

• 1 other identifier: s66033-aim2
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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?

Conditions

Lower Limb Lymphedema

Keywords

screening; urogenital cancer; gynaecological cancer; skin cancer; lymph node dissection

Outcome Measures

Primary Outcomes (3)

• Sensitivity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL

  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

  up to 12 months post-surgery

• Specificity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL

  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

  up to 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

  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

  up to 12 months post-surgery

Secondary Outcomes (29)

• 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 age' 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

Study Arms (1)

lymph node dissection for treatment of urogenital, gynaelogical or skin cancer

Patients with any type of skin melanoma (at the level of the lower limb), urogenital or gynaecological cancer scheduled for lymph node dissection

Diagnostic Test: clinical assessment

Interventions

clinical assessment DIAGNOSTIC_TEST

screening of patients at risk for developing unilateral or bilateral lower limb lymphedema

lymph node dissection for treatment of urogenital, gynaelogical or skin cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Pregnant participants
• Presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Hospitals of Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Urogenital Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tessa De Vrieze, Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa De Vrieze, Dr.

CONTACT

003216345006; tessa.devrieze@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral research fellow and physiotherapist, PhD in Biomedical Sciences (Catholic University of Leuven) and Medical Sciences (University of Antwerp)

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

BE (1)