Liquid Biopsy Collection Study

December 3, 2024 updated by: University of Central Florida

Collection of Human Blood for Development of Liquid Biopsy Assay

The purpose of this study is to develop a liquid biopsy approach for detection of circulating tumor cells (CTC) that could be used in place of the more invasive and potentially risky methods of tissue biopsy. The aims of the project are: (a) determine whether the Chaperonin-Containing TCP-1 (CCT) chaperonin can used to identify rare cancer cells in blood, and (b) establish whether the cancer cells detected using the CCT chaperonin for identification have invasive or metastatic potential.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32816
        • University of Central Florida

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The researchers anticipate that the sample size of 60 will be adequate for statistical analysis.

Description

Inclusion Criteria:

  • Male or female
  • Age greater than or equal to 18 and less than or equal to 80 years.

Exclusion Criteria:

  • Adults unable to give informed consent
  • Individuals who are not yet adults (infants, children, teenagers; under the age of 18)
  • Individuals who weigh less than 110 lbs (as standard clinically advised to not give blood)
  • Pregnant women (due to hormonal changes in blood)
  • Prisoners
  • Persons reporting a current microbial (bacterial, viral, or fungal) infections
  • Persons reporting that they are current taking antibiotic medications
  • Persons with body temperatures above 99oF (indicating a fever)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if the biomarker, Chaperonin-Containing TCP-1 (CCT), can be used to detect circulating tumor cells (CTC) in blood.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine if the CCT chaperonin can provide information on the metastatic potential of CTC.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Investigators

  • Principal Investigator: Annette Khaled, PhD, University of Central Florida

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 Major Dates

Study Start (Actual)

October 7, 2021

Primary Completion (Actual)

October 31, 2023

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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