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Biorepository of Biomarkers for Optimization of Microvascular Treatment of Lymphedema

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ClinicalTrials.gov Identifier: NCT04123457
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
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
Lymphedema

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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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04123457


Contacts
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Contact: Antonio Forte, MD, PhD 904-953-2073 forte.antonio@mayo.edu
Contact: Mauricia Buchanan, RN 904-953-2073 buchanan.mauricia@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Antonio Forte, MD, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Antonio Forte, MD, PhD Mayo Clinic

Additional Information:
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Responsible Party: Antonio J. Forte, Principal Investigator, Mayo Clinic
ClinicalTrials.gov 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases