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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03687749




Registration number
NCT03687749
Ethics application status
Date submitted
10/07/2018
Date registered
27/09/2018

Titles & IDs
Public title
Presentation of First Time Attenders at Lymphedema Clinics
Scientific title
Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
Secondary ID [1] 0 0
S59883
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphedema 0 0
Breast Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women with breast cancer-related lymphedema - Individuals with upper limb lymphedema developed after breast cancer treatment

Healthy control subjects - Healthy individuals without breast cancer-related lymphoedema.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Extracellular fluid in the arm
Timepoint [1] 0 0
immediately after inclusion in the study
Primary outcome [2] 0 0
Arm volume
Timepoint [2] 0 0
immediately after inclusion in the study
Primary outcome [3] 0 0
Pitting
Timepoint [3] 0 0
immediately after inclusion in the study
Secondary outcome [1] 0 0
Self-reported signs and symptoms of lymphedema
Timepoint [1] 0 0
immediately after inclusion in the study
Secondary outcome [2] 0 0
Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema
Timepoint [2] 0 0
immediately after inclusion in the study
Secondary outcome [3] 0 0
Global Health Status/Quality of Life Score
Timepoint [3] 0 0
immediately after inclusion in the study
Secondary outcome [4] 0 0
Body perception
Timepoint [4] 0 0
immediately after inclusion in the study
Secondary outcome [5] 0 0
Pain intensity assessed with the Numeric Rating Scale
Timepoint [5] 0 0
immediately after inclusion in the study
Secondary outcome [6] 0 0
Prevalence of neuropathic pain
Timepoint [6] 0 0
immediately after inclusion in the study
Secondary outcome [7] 0 0
Tactile acuity (Two-point discrimination)
Timepoint [7] 0 0
immediately after inclusion in the study
Secondary outcome [8] 0 0
Mechanical detection and pain threshold
Timepoint [8] 0 0
immediately after inclusion in the study
Secondary outcome [9] 0 0
Temporal summation
Timepoint [9] 0 0
immediately after inclusion in the study

Eligibility
Key inclusion criteria
* women after breast cancer (> 18 years) with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor
* able to give consent to participate in the research
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* patients under the age of 18 years

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2020
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney, Faculty of Health Sciences - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven

Funding & Sponsors
Primary sponsor type
Other
Name
Universitaire Ziekenhuizen KU Leuven
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
An De Groef, PhD
Address 0 0
Universitaire Ziekenhuizen KU Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03687749