Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Breast Cancer-Related Arm Lymphedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978754
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
Breast cancer is a common malignant disease that threatens the health of women.As a serious chronic condition from breast cancer treatment, lymphedema, is caused by chronic accumulation of lymph fluid in the interstitial spaces of the affected limb or surrounding areas.Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45% One reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、limb volume measurement、bioimpedance spectroscopy (BIS) and self-report.Each of these methods has advantages and disadvantages . As a new method for detecting lymphedema ,some study have shown indocyanine green(ICG)lymphography can have a certain value for the detection of subclinical edema。Early detection demonstrate the greatest promise of reducing the incidence of late-stage lymphedema in breast cancer patients undergoing surgery.The aim of this study was therefore to examine the relationships between the most commonly used measures of lymphedema and the respective reliability of each of these tools. And if it's possible ,investigators are going to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema as well as the value of indocyanine green(ICG)in detecting sub-clinical lymphedema.

Condition or disease Intervention/treatment
Breast Neoplasms Diagnostic Test: ICG、CM、VM、BIS、self-report

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Breast Cancer-Related Arm Lymphedema—Comparison of Traditional Measurement Methods and Indocyanine Green(ICG)Lymphography
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with lymphedema Diagnostic Test: ICG、CM、VM、BIS、self-report
ways to examine lymphedema
Other Name: ICG =indocyanine green




Primary Outcome Measures :
  1. Sensitivity and specificity of indocyanine green (ICG) lymphography [ Time Frame: From date of enrollment until the date of first documented lymphedema, assessed up to 2 years. ]
    Sensitivity means the ability of detecting patients with true edema. Specificity means the ability of detecting non-edema patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who visit the clinic
Criteria

Inclusion Criteria:

  • Patients with breast cancer who underwent axillary, axillary and other axillary surgery.
  • Patients who have complaints about upper extremity edema and are willing to undergo examination.
  • Sign the informed consent.

Exclusion Criteria:

  • Bilateral breast cancer.
  • A history of allergy to contrast agents.
  • There are arteriovenous thrombosis in the affected limb.
  • Regional lymph node recurrence
  • Did not sign informed consent.
  • Serious heart, brain and other diseases.
  • The primary lymphatic system diseases (such as lymphatic leakage).
  • Only one side of the limb received ICG angiography.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978754


Contacts
Layout table for location contacts
Contact: liu siyao +86 18801229921 dr.liusiyao@pku.edu.cn

Locations
Layout table for location information
China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China
Contact: liu siyao    +86 18801229921    doc_lsy@163.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wang Shu Peking University People's Hospital

Layout table for additonal information
Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03978754     History of Changes
Other Study ID Numbers: PUPH18050101
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
Lymphedema of Upper Arm
Breast Neoplasms
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases
Postoperative Complications
Pathologic Processes