NCT07091058

Brief Summary

The purpose of this study is to compare the frequency of symptoms, exposure and health impacts in persons living in areas where they are exposed to bloom and non-bloom periods of cyanobacteria and red tide in Florida.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress91%
Nov 2024Jun 2026

Study Start

First participant enrolled

November 13, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

Red Tide

Keywords

algaeCyanobacteriared tidecyanotoxinHarmful Algal Blooms (HABs)microcystinsbrevetoxin

Outcome Measures

Primary Outcomes (1)

  • To correlate self- reported symptom occurrence with recreational/occupational cyanotoxin exposure (measured in air and water environmental samples) and cyanotoxin levels in blood, nasal swab

    These data will be linked to determine if and how much contact the participant may have had with Florida waters, presence of cyanotoxin in the bio samples (blood, nasal swabs, and urine) and self-reported health issues to determine the impact of harmful algal blooms (HABs) on human health. In addition, this study will explore a potential link between self-reported COVID-19 exposure/infection and susceptibility to cyanotoxins and establish a HAB biorepository.

    2 years

Secondary Outcomes (4)

  • Continue the study of previously enrolled cohort participants prospectively to determine whether long-term effects can be attributed to exposure to microcystins and brevetoxins (Florida Red Tide).

    1 year

  • Recruit and establish new study participants on the West Coast of Florida (coastal Lee County) to further study the health effects of exposure to Red Tide.

    1 year

  • Apply novel approaches to measure biomarkers in samples included in the biobank repository and maintained in the FAU Health Clinical Research Unit using using logistic regression and Generalized Linear Mixed Models (GLMM).

    2 years

  • Analysis of data collected during our previous studies in 2016, 2018, and 2020-2023 to explore risk factors that potentially increase the susceptibility to the respiratory impacts of harmful algal bloom toxin exposure.

    2 years

Study Arms (2)

Questionnaire A

Participants will be assigned to complete Questionnaire A based on if they are new or returning participants and on the status of bloom at consent.

Questionnaire B

Participants will be assigned to complete Questionnaire B based on if they are new or returning participants and on the status of bloom at consent.

Eligibility Criteria

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

The study population will include up to 400 individuals who are 18yrs of age or older, visit, live or work in specific Florida counties and who read and understand English and consent to participation.

You may qualify if:

  • years or older
  • live, visit, and/ or work in the following Florida counties: Indian River, St. Lucie, Charlotte, Collier, Hendry, Hillsborough, Lee, Manatee, Martin, Monroe, Okeechobee, Palm Beach, Pasco, Pinellas, Indian River, and/or Sarasota
  • able to read and understand English

You may not qualify if:

  • unable to independently consent
  • younger than 18 years old
  • prisoner
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Multiple Locations, Florida, 00000, United States

RECRUITING

Study Officials

  • Rebecca Koszalinski, PhD, MS, RN, FIEL, CRRN, FARN

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

14072668742Amoy.Fraser@ucf.edu

Britney-Ann Wray, BS, CTBS, CCRP

CONTACT

4072668742britney-ann.wray@ucf.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

November 13, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations

US(1)