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
About this trial
This is an interventional diagnostic trial for Lymphedema
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
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
NCT ID
NCT04606511
First Posted
October 8, 2020
Last Updated
February 23, 2021
Sponsor
Odense University Hospital
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
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