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Prospective Assessments Following Immediate Lymphatic Reconstruction

NCT ID: NCT07227467

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-30

Study Completion Date

2030-12-31

Brief Summary

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Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema.(Chang et al. 2020) 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. To our knowledge, 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.

Detailed Description

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Conditions

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Lymphatic Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients who are potential candidates for immediate lymphatic reconstruction (ILR)

potential candidates for ILR based on possible nodal involvement assessed preoperatively.

patients who are candidates for immediate lymphatic reconstruction

Intervention Type OTHER

potential candidates for ILR based on possible nodal involvement assessed preoperatively.

Interventions

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patients who are candidates for immediate lymphatic reconstruction

potential candidates for ILR based on possible nodal involvement assessed preoperatively.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

potential candidates for ILR based on possible nodal involvement assessed preoperatively.

Exclusion Criteria

* Individuals who are not eligible for ILR based on possible nodal involvement assessed preoperatively.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Summer Hanson, MD, PhD, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University o Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Summer Hanson, MD, PhD, FACS

Role: CONTACT

Phone: (773) 702-6302

Email: [email protected]

Facility Contacts

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Summer Hanson, MD, PhD, FACS

Role: primary

Other Identifiers

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IRB25-1329

Identifier Type: -

Identifier Source: org_study_id