Liquid Biopsy Collection Study

Circulating Tumor Cells Clinical Trial

Official title:

Collection of Human Blood for Development of Liquid Biopsy Assay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068348
• Other study ID #: STUDY00003221
• Status: Recruiting
• Start date: October 7, 2021
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: University of Central Florida
• Contact: Amoy Fraser, PhD, CCRP, PMP
• Phone: 407-266-8742
• Email: amoy.fraser[@]ucf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if the biomarker, Chaperonin-Containing TCP-1 (CCT), can be used to detect circulating tumor cells (CTC) in blood.		3 years
Secondary	To determine if the CCT chaperonin can provide information on the metastatic potential of CTC.		3 years