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New treatment option for Lymphedema
Official title Lymphedema After Gyneco-oncologic Treatment
ClinicalTrials.gov ID: NCT05469945
What this study is testing
- What it's testing
- Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer. Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, women only
You may be able to join if
- Signed informed consent (ICF)
- Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment
- Age ≥ 18 years
- Understanding of the Dutch language
- Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested...
You likely can't join if
- History of treatment for gynaecologic cancer
- Concurrent second primary tumor(s)
- Pregnancy or pregnancy planned within 2 years
- Known metastasized cancer at the time of inclusion (D0)
- Severe injury, surgery or deformation of the legs or groins in the past
- Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more)
See the full eligibility criteria
- Signed informed consent (ICF)
- Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment
- Age ≥ 18 years
- Understanding of the Dutch language
- Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires.
- History of treatment for gynaecologic cancer
- Concurrent second primary tumor(s)
- Pregnancy or pregnancy planned within 2 years
- Known metastasized cancer at the time of inclusion (D0)
- Severe injury, surgery or deformation of the legs or groins in the past
- Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more)
- Mental or psychological problems, inability to comply to the study protocol
- First treatment administered \> 2 weeks before
- Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.