Liquid Biopsy Collection Study

NCT06068348 | Active Not Recruiting

• 1 other identifier: STUDY00003221
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chaperonin-Containing TCP-1; Circulating Tumor Cells; CCT; CTC

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• To determine if the biomarker, Chaperonin-Containing TCP-1 (CCT), can be used to detect circulating tumor cells (CTC) in blood.

  3 years

Secondary Outcomes (1)

• To determine if the CCT chaperonin can provide information on the metastatic potential of CTC.

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annette Khaled, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: October 7, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)