RECRUITING

Extracellular Vesicles for HD

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to discover blood-based biomarker of brain Huntingtin (HTT) protein using extracellular vesicles to be used in evaluating target engagement in HTT lowering clinical trials. Secondary objectives of this study include developing more accurate biomarkers of Huntington disease (HD) progression or conversion and to develop standard practices for extracellular vesicle biomarker discovery research. The investigators hypothesize that brain-derived extracellular vesicles (EVs) isolated from human biofluids contain biological cargo specific to their tissue of origin that could allow their use as brain biomarkers for HD. EVs are lipid bilayer-delimited particles that are naturally released from cells in the brain. The investigators will investigate if EVs contents reflect the pathological alterations occurring with disease progression when compared with EVs isolated from biofluids of healthy non-HD persons.

Official Title

Extracellular Vesicles As Non-Invasive Biomarkers for Huntington Disease Progression and Huntingtin Lowering Therapy

Quick Facts

Study Start:2023-10-25

Study Completion:2031-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06082713

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 - 75 years of age 2. can provide informed consent 3. able to read and speak English 4. agree to comply with study procedures (including overnight fasting, blood collection and lumbar puncture); and 5. has been diagnosed with HD (HD Carriers) or not been diagnosed with HD (Non-HD Carriers).	1. younger than 18 or older than 75 years old 2. known to carry an intermediate CAG repeat between 27 and 39 or a larger expansion of 60 or more CAG repeats 3. receiving nutrition through a tube 4. pregnant 5. participated in a clinical drug trial within 30 days 6. use prescribed or non-prescribed medications that are not compatible with collection of the study samples (those that may cause excessive bleeding or prevent clotting) 7. positive for HIV, hepatitis B or C 8. have a confirmed or suspected immunodeficient condition/state 9. significant medical, psychiatric, or neurological morbidity is observed by the clinic physician on the day of sample collection that might impair completion of the study procedures 10. have needle phobia, frequent headache, significant lower spinal deformity or major surgery 11. received antiplatelet or anticoagulant therapy within 14 days prior to sample collection (including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban) 12. have a blood clotting or bruising disorder 13. do not comply with or are unwilling to undertake any of the study procedures

Inclusion Criteria

Exclusion Criteria

1. 18 - 75 years of age
2. can provide informed consent
3. able to read and speak English
4. agree to comply with study procedures (including overnight fasting, blood collection and lumbar puncture); and
5. has been diagnosed with HD (HD Carriers) or not been diagnosed with HD (Non-HD Carriers).

1. younger than 18 or older than 75 years old
2. known to carry an intermediate CAG repeat between 27 and 39 or a larger expansion of 60 or more CAG repeats
3. receiving nutrition through a tube
4. pregnant
5. participated in a clinical drug trial within 30 days
6. use prescribed or non-prescribed medications that are not compatible with collection of the study samples (those that may cause excessive bleeding or prevent clotting)
7. positive for HIV, hepatitis B or C
8. have a confirmed or suspected immunodeficient condition/state
9. significant medical, psychiatric, or neurological morbidity is observed by the clinic physician on the day of sample collection that might impair completion of the study procedures
10. have needle phobia, frequent headache, significant lower spinal deformity or major surgery
11. received antiplatelet or anticoagulant therapy within 14 days prior to sample collection (including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban)
12. have a blood clotting or bruising disorder
13. do not comply with or are unwilling to undertake any of the study procedures

Contacts and Locations

Study Contact

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742

amoy.fraser@ucf.edu

Erica Martin, B.S.

CONTACT

4072668742

erica.martin@ucf.edu

Principal Investigator

Amber Southwell, PhD

PRINCIPAL_INVESTIGATOR

University of Central Florida Burnett School of Biomedical Sciences

Study Locations (Sites)

University of Central Florida

Orlando, Florida, 32816

United States

Collaborators and Investigators

Sponsor: University of Central Florida

Amber Southwell, PhD, PRINCIPAL_INVESTIGATOR, University of Central Florida Burnett School of Biomedical Sciences

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 Registration Dates

Study Start Date2023-10-25

Study Completion Date2031-11

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2031-11

Terms related to this study

Keywords Provided by Researchers

HD
Huntington Disease
Healthy

Additional Relevant MeSH Terms

Huntington Disease