Lymphedema Screening (LymphScreen)

February 23, 2021 updated by: Mads Gustaf Jørgensen, Odense University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Department of plastic and reconstructive Surgery
        • Contact:
        • Contact:
          • Jens A Sørensen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Breast cancer patients with lymphedema
Diagnostic test: Circumference tape measurements
centimeter and volume criterias
Diagnostic test: Indocyanine green lymphangiography
Presence of dermal backflow
Diagnostic test: bioimpedance spectroscopy
7.5 and 10 L-DEX criterias
Diagnostic test: Symptom score
using lymph-icf, DASH and SF-36 questionnaires
OTHER: Breast cancer patients without lymphedema
Diagnostic test: Circumference tape measurements
centimeter and volume criterias
Diagnostic test: Indocyanine green lymphangiography
Presence of dermal backflow
Diagnostic test: bioimpedance spectroscopy
7.5 and 10 L-DEX criterias
Diagnostic test: Symptom score
using lymph-icf, DASH and SF-36 questionnaires

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2020

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (ACTUAL)

October 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20200094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

5 years after study completion

IPD Sharing Access Criteria

Upon reasonable request

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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