Lymphedema Screening

Screening for Lymphedema

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04606511

Acronym

LymphScreen

Enrollment

250

Registered

2020-10-28

Start date

2020-10-05

Completion date

2021-10-31

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Brief 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. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.

Interventions

DIAGNOSTIC_TESTCircumference tape measurements

centimeter and volume criterias

DIAGNOSTIC_TESTIndocyanine green lymphangiography

Presence of dermal backflow

DIAGNOSTIC_TESTbioimpedance spectroscopy

7.5 and 10 L-DEX criterias

DIAGNOSTIC_TESTSymptom score

using lymph-icf, DASH and SF-36 questionnaires

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Previous breast cancer treated with axillary lymph node dissection * No recurrence * Understand the study * Can talk, read and understand Danish

Exclusion criteria

* Pregnant or breast feeding * Lymph node dissection from other basins * Psychiatric disorder * Not possible to perform indocyanine green lymphangiography

Design outcomes

Primary

Measure	Time frame	Description
sensitivity, specificy, NPV and PPV	through study completion, approximately 1 year	diagnosotic statistics of lymphedema measurements

Countries

Denmark

Contacts

Primary ContactMads G Jørgensen, MD

Mads.Gustaf.Jorgensen@rsyd.dk29210114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026