Lower Limb LymphedemaEvaLymph-Leg2NCT05421377
Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 2
An observational study of Lower Limb Lymphedema, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Lymphedema
- What is being tested?
- clinical assessment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2022to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals of Leuven
Leuven, 3000
Tessa De Vrieze, Dr., 003216345006, tessa.devrieze@kuleuven.be
About this study
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
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.
Read more
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
- Being tested
- clinical assessment
- Keywords
- screening, urogenital cancer, gynaecological cancer, skin cancer, lymph node dissection
- Medical subject headings
- Urogenital Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessmentDiagnostic test
screening of patients at risk for developing unilateral or bilateral lower limb lymphedema
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Dependent variable = presence of lower limb lymphoedema Independent variable= Age (years) will be self-reported through interview.
Measured: 6 weeks post-surgery
Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 12 months post-surgery.
Dependent variable = presence of lower limb lymphoedema Independent variable= Age (years) will be self-reported through interview.
Measured: 12 months post-surgery
Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Baseline physical activity level : will be assessed with the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Measured: 6 weeks post-surgery
Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Baseline physical activity level : will be assessed with the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity.
Measured: 12 months post-surgery
Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Educational level: will be self-reported through interview.
Measured: 6 weeks post-surgery
Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Educational level: will be self-reported through interview.
Measured: 12 months post-surgery
Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 6 weeks post- surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= baseline Body Mass Index
Measured: 6 weeks post- surgery
Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 12 months post- surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= baseline Body Mass Index
Measured: 12 months post- surgery
Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= baseline comorbidities
Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.
Measured: 6 weeks post-surgery
Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= baseline comorbidities
Comorbidities will be reported through a self-developed co-morbidity questionnaire, based on IDEWE questionnaire.
Measured: 12 months post-surgery
Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Type of cancer Information regarding the type of cancer is collected by exploring the patient's medical file.
Measured: 6 weeks post-surgery
Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Type of cancer Information regarding the type of cancer is collected by exploring the patient's medical file.
Measured: 12 months post-surgery
Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Tumor stage
Information regarding the tumor stage of is collected by exploring the patient's medical file.
Measured: at 6 weeks post-surgery
Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Tumor stage
Information regarding the tumor stage of is collected by exploring the patient's medical file.
Measured: 12 months post-surgery
Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Lymph node stage
Information regarding the lymph node stage of is collected by exploring the patient's medical file.
Measured: 6 weeks post-surgery
Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable= Lymph node stage
Information regarding the lymph node stage of is collected by exploring the patient's medical file.
Measured: 12 months post-surgery
Prognostic value of 'Number of positive lymph nodes' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Dependent variable = presence of lower limb lymphoedema Independent variable=Number of positive lymph nodes: is collected through the patient's medical file.
Measured: 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
Dependent variable = presence of lower limb lymphoedema Independent variable=Number of positive lymph nodes: is collected through the patient's medical file.
Measured: 12 months post-surgery
Prognostic value of 'Postoperative complications' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Information regarding the complications related to the surgery as well as adjuvant therapies is collected. Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 6 weeks post-surgery
Prognostic value of 'Postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery
Information regarding the complications related to the surgery as well as adjuvant therapies is collected. Surgical complications will be assessed according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 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
Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.
Type of lymph node dissection: Limited- Standard- Extended- Super extended
Measured: 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
Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.
Type of lymph node dissection: Limited- Standard- Extended- Super extended
Measured: 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
Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.
Measured: 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
Cancer treatment characteristics are collected (i.e. type of surgery, type of lymph node dissection, number of lymph nodes removed, presence of postoperative drain, number of positive lymph nodes, adjuvant therapies; by exploring the patient's medical file.
Measured: 12 months post-surgery
Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.
Measured: 6 weeks post-surgery
Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Cancer treatment characteristics , including adjuvant radiotherapy are collected; by exploring the patient's medical file.
Measured: 12 months post-surgery
Incidence rate of unilateral and bilateral LLL at 6 weeks post-surgery
Calculation of the proportion of patients with leg (or foot) lymphedema, defined as 5.0% or more increase of the leg (or foot) volume in each leg (or foot), at a certain time point, compared to the volumes at baseline; OR patients with a score of at least 5 out of 52 on the detect-OL questionnaire in case it is clearly indicated whether symptoms are present in one or both legs (in order to be able to categorize patients to the "unilateral LLL" or "bilateral LLL" group).
Additionally, the proportion of presence of LLL in patients having received a lymph node dissection due to gynaecological cancer vs. due to urogenital cancer vs. due to skin melanoma will be compared. The distribution of LLL (unilateral vs. bilateral, regions of the lower limb) will be encountered and compared.
Measured: 6 weeks post-surgery
Incidence rate of unilateral and bilateral LLL at 6 months post-surgery
Calculation of the proportion of patients with leg (or foot) lymphedema, defined as 5.0% or more increase of the leg (or foot) volume in each leg (or foot), at a certain time point, compared to the volumes at baseline; OR patients with a score of at least 5 out of 52 on the detect-OL questionnaire in case it is clearly indicated whether symptoms are present in one or both legs (in order to be able to categorize patients to the "unilateral LLL" or "bilateral LLL" group).
Additionally, the proportion of presence of LLL in patients having received a lymph node dissection due to gynaecological cancer vs. due to urogenital cancer vs. due to skin melanoma will be compared. The distribution of LLL (unilateral vs. bilateral, regions of the lower limb) will be encountered and compared.
Measured: 6 months post-surgery
Incidence rate of unilateral and bilateral LLL at 12 months post-surgery
Calculation of the proportion of patients with leg (or foot) lymphedema, defined as 5.0% or more increase of the leg (or foot) volume in each leg (or foot), at a certain time point, compared to the volumes at baseline; OR patients with a score of at least 5 out of 52 on the detect-OL questionnaire in case it is clearly indicated whether symptoms are present in one or both legs (in order to be able to categorize patients to the "unilateral LLL" or "bilateral LLL" group).
Additionally, the proportion of presence of LLL in patients having received a lymph node dissection due to gynaecological cancer vs. due to urogenital cancer vs. due to skin melanoma will be compared. The distribution of LLL (unilateral vs. bilateral, regions of the lower limb) will be encountered and compared.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Oct 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb LymphedemaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Tessa De Vrieze, KU Leuven
- Investigators
- Tessa De Vrieze, Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421377
- Sponsor's protocol ID
- s66033-aim2
- Acronym
- EvaLymph-Leg2
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05421377
- Acronym / sponsor ID
- EvaLymph-Leg2 / s66033-aim2
- Conditions
- Lower Limb Lymphedema
- Keywords
- screening, urogenital cancer, gynaecological cancer, skin cancer, lymph node dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lymph node dissection for treatment of urogenital, gynaelogical or skin cancer | – | Diagnostic Test: clinical assessmentPatients with any type of skin melanoma (at the level of the lower limb), urogenital or gynaecological cancer scheduled for lymph node dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical assessmentscreening of patients at risk for developing unilateral or bilateral lower limb lymphedema | Diagnostic test | lymph node dissection for treatment of urogenital, gynaelogical or skin cancer |
Primary outcome
Sensitivity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
Time frame: 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
Specificity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL
Time frame: 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
Time frame: 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
29 secondary outcomes
Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of 'baseline age' for the development of bilateral lower limb lymphoedema at 12 months post-surgery.
Time frame: 12 months post-surgery
Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of ' Baseline physical activity level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of ' Baseline educational level' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 6 weeks post- surgery
Time frame: 6 weeks post- surgery
Prognostic value of ' Baseline BMI' for the development of bilateral lower limb lymphoedema at 12 months post- surgery
Time frame: 12 months post- surgery
Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of ' Baseline comorbidities' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of 'Type of cancer' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: at 6 weeks post-surgery
Prognostic value of 'Tumor stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of 'Lymph node stage' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Prognostic value of 'Number of positive lymph nodes' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 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
Time frame: 12 months post-surgery
Prognostic value of 'Postoperative complications' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of 'Postoperative complications' for the development of lower limb lymphoedema at 12 months post-surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months post-surgery
Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Prognostic value of 'Adjuvant Radiotherapy' for the development of bilateral lower limb lymphoedema at 12 months post-surgery
Time frame: 12 months post-surgery
Incidence rate of unilateral and bilateral LLL at 6 weeks post-surgery
Time frame: 6 weeks post-surgery
Incidence rate of unilateral and bilateral LLL at 6 months post-surgery
Time frame: 6 months post-surgery
Incidence rate of unilateral and bilateral LLL at 12 months post-surgery
Time frame: 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tessa De Vrieze, Dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Lymphedema, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tessa De Vrieze, Dr. (003216345006, tessa.devrieze@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of reliable and clinical feasible measurement methods regarding the screening of patients at risk for developing unilateral or bilateral LLL (time frame: up to 12 months post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.