Liquid Biopsy Collection Study | NCT06068348

Studies
Liquid Biopsy Collection Study

NCT06068348

Sponsor

University of Central Florida

Status

Active, not recruiting

Last Update Posted

Dec 6, 2024Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Chaperonin-Containing TCP-1
Circulating Tumor Cells
CCT
CTC

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2021Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 2025Estimated

First Submitted Date

Sep 28, 2023

First Submission Date that Met QC Criteria

Sep 28, 2023

First Posted Date

Oct 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annette Khaled, PhD	University of Central Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Central Florida		Orlando	Florida	32816	United States

Condition Browse Module

MeSH Terms

ID	Term
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided