LymphedemaLymphScreenNCT04606511
Lymphedema Screening
A study testing Circumference tape measurements, Indocyanine green lymphangiography and bioimpedance spectroscopy in people with Lymphedema, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphedema
- What is being tested?
- Circumference tape measurements, Indocyanine green lymphangiography and bioimpedance spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Oct 2020to Oct 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Previous breast cancer treated with axillary lymph node dissection
- No recurrence
- Understand the study
- Can talk, read and understand Danish
Who cannot join
- Pregnant or breast feeding
- Lymph node dissection from other basins
- Psychiatric disorder
- Not possible to perform indocyanine green lymphangiography
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Plastic and Reconstructive Surgery
Odense, 5000
Mads G Jørgensen, MD, Mads.Gustaf.Jorgensen@rsyd.dk
Jens A Sørensen, MD, PhD
About this study
Official title: Screening for Lymphedema
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.
- Conditions
- Lymphedema
- Being tested
- Circumference tape measurements, Indocyanine green lymphangiography, bioimpedance spectroscopy, Symptom score
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumference tape measurementsDiagnostic test
centimeter and volume criterias
Indocyanine green lymphangiographyDiagnostic test
Presence of dermal backflow
bioimpedance spectroscopyDiagnostic test
7.5 and 10 L-DEX criterias
Symptom scoreDiagnostic test
using lymph-icf, DASH and SF-36 questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with lymphedema | Other | Not described Receives: Diagnostic Test: Circumference tape measurements; Diagnostic Test: Indocyanine green lymphangiography; Diagnostic Test: bioimpedance spectroscopy; Diagnostic Test: Symptom score |
| Breast cancer patients without lymphedema | Other | Not described Receives: Diagnostic Test: Circumference tape measurements; Diagnostic Test: Indocyanine green lymphangiography; Diagnostic Test: bioimpedance spectroscopy; Diagnostic Test: Symptom score |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity, specificy, NPV and PPV
diagnosotic statistics of lymphedema measurements
Measured: through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start5 Oct 2020
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Gustaf Jørgensen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606511
- Sponsor's protocol ID
- S-20200094
- Acronym
- LymphScreen
- Status last verified
- Feb 2021
- First submitted
- 8 Oct 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Lymphedema
- ClinicalTrials.gov ID
- NCT04606511
- Acronym / sponsor ID
- LymphScreen / S-20200094
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Oct 2020 (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.
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with lymphedema | Other | Diagnostic Test: Circumference tape measurements, Diagnostic Test: Indocyanine green lymphangiography, Diagnostic Test: bioimpedance spectroscopy, Diagnostic Test: Symptom score |
| Breast cancer patients without lymphedema | Other | Diagnostic Test: Circumference tape measurements, Diagnostic Test: Indocyanine green lymphangiography, Diagnostic Test: bioimpedance spectroscopy, Diagnostic Test: Symptom score |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Previous breast cancer treated with axillary lymph node dissection
- No recurrence
- Understand the study
- Can talk, read and understand Danish
Key exclusion criteria (4 listed)
- Pregnant or breast feeding
- Lymph node dissection from other basins
- Psychiatric disorder
- Not possible to perform indocyanine green lymphangiography
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 |
|---|---|---|
| Circumference tape measurementscentimeter and volume criterias | Diagnostic test | Breast cancer patients with lymphedema, Breast cancer patients without lymphedema |
| Indocyanine green lymphangiographyPresence of dermal backflow | Diagnostic test | Breast cancer patients with lymphedema, Breast cancer patients without lymphedema |
| bioimpedance spectroscopy7.5 and 10 L-DEX criterias | Diagnostic test | Breast cancer patients with lymphedema, Breast cancer patients without lymphedema |
| Symptom scoreusing lymph-icf, DASH and SF-36 questionnaires | Diagnostic test | Breast cancer patients with lymphedema, Breast cancer patients without lymphedema |
Primary outcome
sensitivity, specificy, NPV and PPV
Time frame: through study completion, approximately 1 year
diagnosotic statistics of lymphedema measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Yes
Related trials for Lymphedema
Not yet recruiting
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Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumference tape measurements, Indocyanine green lymphangiography and bioimpedance spectroscopy in people with Lymphedema, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 4 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 24 Feb 2021. 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 Denmark. 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 Mads G Jørgensen, MD (29210114 ext. +45, Mads.Gustaf.Jorgensen@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity, specificy, NPV and PPV (time frame: through study completion, approximately 1 year). 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 24 Feb 2021.