RECRUITING

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.

Official Title

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Quick Facts

Study Start:2024-11-26
Study Completion:2029-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06650592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)
  1. * None

Contacts and Locations

Study Contact

Summer Hanson, MD, PhD, FACS
CONTACT
(773) 702-6302
sehanson@bsd.uchicago.edu
Leila Yazdanbakhsh
CONTACT
773-834-5087
leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator

Summer Hanson, MD, PhD, FACS
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

The University o Chicago
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Summer Hanson, MD, PhD, FACS, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26
Study Completion Date2029-10

Study Record Updates

Study Start Date2024-11-26
Study Completion Date2029-10

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphatic Reconstruction