Working… Menu

Biorepository of Biomarkers for Optimization of Microvascular Treatment of 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. Identifier: NCT04123457
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Information provided by (Responsible Party):
Antonio J. Forte, Mayo Clinic

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

Condition or disease

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Biorepository for Discovery and Validation of Biomarkers for Optimization of Microvascular Treatment of Lymphedema
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Primary Outcome Measures :
  1. Biospecimen Acquisition [ Time Frame: 1 year ]
    Number of biospecimens collected

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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a diagnosis of Lymphedema.

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

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 identifier (NCT number): NCT04123457

Layout table for location contacts
Contact: Antonio Forte, MD, PhD 904-953-2073
Contact: Mauricia Buchanan, RN 904-953-2073

Layout table for location information
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Antonio Forte, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Layout table for investigator information
Principal Investigator: Antonio Forte, MD, PhD Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Antonio J. Forte, Principal Investigator, Mayo Clinic Identifier: NCT04123457     History of Changes
Other Study ID Numbers: 18-006576
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphatic Diseases