Biorepository of Biomarkers for Optimization of Microvascular Treatment of Lymphedema

September 12, 2023 updated by: Antonio J. Forte, Mayo Clinic

Biorepository for Discovery and Validation of Biomarkers for Optimization of Microvascular Treatment of Lymphedema

Researchers are collecting information, saliva, blood and tissue from subjects with lymphedema to store for future research.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with a diagnosis of Lymphedema.

Description

Inclusion Criteria:

  • Adult (18+ years of age)
  • Ability to provide written consent
  • Has been diagnosed with Lymphedema

Exclusion Criteria:

  • Under the age of 18 years old
  • Inability to provide written consent
  • Previous lymphovenous bypass or lymph node transfer surgery
  • Major changes occur to co-morbid conditions
  • Proven ICG or iodine allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biospecimen Acquisition
Time Frame: 1 year
Number of biospecimens collected
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Antonio Forte, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-006576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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