NCT05300308 Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer
| NCT ID | NCT05300308 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Urogenital Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-01-21 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-01-21 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated. Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).
Eligibility Criteria
Inclusion Criteria: * Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer) * Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection * Salvage lymph node dissection * Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan * Clinical signs of chronic venous insufficiency (CEAP C3-C6) * History of lymph node dissection/ radiotherapy at the level of the pelvis or groin
Contact & Investigator
Nele Devoogdt, Prof. Dr.
PRINCIPAL INVESTIGATOR
UZ Leuven
Frequently Asked Questions
Who can join the NCT05300308 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urogenital Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05300308 currently recruiting?
Yes, NCT05300308 is actively recruiting participants. Contact the research team at nele.devoogdt@uzleuven.be for enrollment information.
Where is the NCT05300308 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05300308 clinical trial?
NCT05300308 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Nele Devoogdt, Prof. Dr. at UZ Leuven. The trial plans to enroll 150 participants.
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