NCT04123457

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Aug 2019Aug 2027

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

7 years

First QC Date

October 9, 2019

Last Update Submit

September 29, 2025

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Biospecimen Acquisition

    Number of biospecimens collected

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a diagnosis of Lymphedema.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Antonio Forte, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2019

First Posted

October 11, 2019

Study Start

August 1, 2019

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)