NCT04606511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

October 8, 2020

Last Update Submit

February 23, 2021

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

  • sensitivity, specificy, NPV and PPV

    diagnosotic statistics of lymphedema measurements

    through study completion, approximately 1 year

Study Arms (2)

Breast cancer patients with lymphedema

OTHER
Diagnostic Test: Circumference tape measurementsDiagnostic Test: Indocyanine green lymphangiographyDiagnostic Test: bioimpedance spectroscopyDiagnostic Test: Symptom score

Breast cancer patients without lymphedema

OTHER
Diagnostic Test: Circumference tape measurementsDiagnostic Test: Indocyanine green lymphangiographyDiagnostic Test: bioimpedance spectroscopyDiagnostic Test: Symptom score

Interventions

Circumference tape measurementsDIAGNOSTIC_TEST

centimeter and volume criterias

Breast cancer patients with lymphedemaBreast cancer patients without lymphedema
Indocyanine green lymphangiographyDIAGNOSTIC_TEST

Presence of dermal backflow

Breast cancer patients with lymphedemaBreast cancer patients without lymphedema
bioimpedance spectroscopyDIAGNOSTIC_TEST

7.5 and 10 L-DEX criterias

Breast cancer patients with lymphedemaBreast cancer patients without lymphedema
Symptom scoreDIAGNOSTIC_TEST

using lymph-icf, DASH and SF-36 questionnaires

Breast cancer patients with lymphedemaBreast cancer patients without lymphedema

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic and Reconstructive Surgery

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Mads G Jørgensen, MD

CONTACT

29210114Mads.Gustaf.Jorgensen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 28, 2020

Study Start

October 5, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE
Time Frame
5 years after study completion
Access Criteria
Upon reasonable request

Locations

DK(1)