search
Back to results

Lymphedema Screening (LymphScreen)

Primary Purpose

Lymphedema

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Circumference tape measurements
Indocyanine green lymphangiography
bioimpedance spectroscopy
Symptom score
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphedema

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Plastic and Reconstructive SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Breast cancer patients with lymphedema

Breast cancer patients without lymphedema

Arm Description

Outcomes

Primary Outcome Measures

sensitivity, specificy, NPV and PPV
diagnosotic statistics of lymphedema measurements

Secondary Outcome Measures

Full Information

First Posted
October 8, 2020
Last Updated
February 23, 2021
Sponsor
Odense University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04606511
Brief Title
Lymphedema Screening
Acronym
LymphScreen
Official Title
Screening for Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast cancer patients with lymphedema
Arm Type
Other
Arm Title
Breast cancer patients without lymphedema
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Circumference tape measurements
Intervention Description
centimeter and volume criterias
Intervention Type
Diagnostic Test
Intervention Name(s)
Indocyanine green lymphangiography
Intervention Description
Presence of dermal backflow
Intervention Type
Diagnostic Test
Intervention Name(s)
bioimpedance spectroscopy
Intervention Description
7.5 and 10 L-DEX criterias
Intervention Type
Diagnostic Test
Intervention Name(s)
Symptom score
Intervention Description
using lymph-icf, DASH and SF-36 questionnaires
Primary Outcome Measure Information:
Title
sensitivity, specificy, NPV and PPV
Description
diagnosotic statistics of lymphedema measurements
Time Frame
through study completion, approximately 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mads G Jørgensen, MD
Phone
29210114
Ext
+45
Email
Mads.Gustaf.Jorgensen@rsyd.dk
Facility Information:
Facility Name
Department of Plastic and Reconstructive Surgery
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mads G Jørgensen, MD
Email
Mads.Gustaf.Jorgensen@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Jens A Sørensen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
5 years after study completion
IPD Sharing Access Criteria
Upon reasonable request

Learn more about this trial

Lymphedema Screening

We'll reach out to this number within 24 hrs