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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04606511
Other study ID # S-20200094
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date October 2021

Study information

Verified date February 2021
Source Odense University Hospital
Contact Mads G Jørgensen, MD
Phone 29210114
Email Mads.Gustaf.Jorgensen@rsyd.dk
Is FDA regulated No
Health authority
Study type Interventional

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


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date October 2021
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Circumference tape measurements
centimeter and volume criterias
Indocyanine green lymphangiography
Presence of dermal backflow
bioimpedance spectroscopy
7.5 and 10 L-DEX criterias
Symptom score
using lymph-icf, DASH and SF-36 questionnaires

Locations

Country Name City State
Denmark Department of Plastic and Reconstructive Surgery Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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