Chaperonin-Containing TCP-1NCT06068348
Liquid Biopsy Collection Study
An observational study of Chaperonin-Containing TCP-1 and Circulating Tumor Cells, run by University of Central Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chaperonin-Containing TCP-1, Circulating Tumor Cells, CCT
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The researchers anticipate that the sample size of 60 will be adequate for statistical analysis.
Who may be able to join
- Male or female
- Age greater than or equal to 18 and less than or equal to 80 years.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: 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.
- Conditions
- Chaperonin-Containing TCP-1, Circulating Tumor Cells, CCT, CTC
- Keywords
- Healthy
- Medical subject headings
- Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the biomarker, Chaperonin-Containing TCP-1 (CCT), can be used to detect circulating tumor cells (CTC) in blood.
Measured: 3 years
Secondary outcomes (1)
To determine if the CCT chaperonin can provide information on the metastatic potential of CTC.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start7 Oct 2021
- Primary completion31 Oct 2023
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chaperonin-Containing TCP-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annette Khaled, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068348
- Sponsor's protocol ID
- STUDY00003221
- Status last verified
- Dec 2024
- First submitted
- 28 Sep 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Human Blood for Development of Liquid Biopsy Assay
- ClinicalTrials.gov ID
- NCT06068348
- Acronym / sponsor ID
- STUDY00003221
- Conditions
- Chaperonin-Containing TCP-1, Circulating Tumor Cells, CCT, CTC
- Keywords
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The researchers anticipate that the sample size of 60 will be adequate for statistical analysis.
Key inclusion criteria (2 listed)
- Male or female
- Age greater than or equal to 18 and less than or equal to 80 years.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To determine if the CCT chaperonin can provide information on the metastatic potential of CTC.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Khaled, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chaperonin-Containing TCP-1 and Circulating Tumor Cells, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.