- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06068348
Liquid Biopsy Collection Study
November 4, 2023 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
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 Contact
- Name: Amoy Fraser, PhD, CCRP, PMP
- Phone Number: 407-266-8742
- Email: amoy.fraser@ucf.edu
Study Contact Backup
- Name: Erica Martin, B.S.
- Phone Number: 407-266-8742
- Email: erica.martin@ucf.edu
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- Recruiting
- University of Central Florida
-
Principal Investigator:
- Annette Khaled, PhD
-
-
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
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 (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
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 (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 4, 2023
Last Verified
November 1, 2023
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
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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