Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Cancer

December 3, 2024 updated by: University of Central Florida

Cell-free Chromatin Immunoprecipitation (CfChIP) from Blood Plasma As a Diagnostic and Prognostic Tool in Pancreatic Ductal Adenocarcinoma

The goal of this research is to use chromatin immunoprecipitation, a method used to study protein-DNA interaction, as a tool to diagnose and prognose pancreatic ductal adenocarcinoma in human samples.

This is a Non-Human Subject Research study. All participants are de-identified.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pancreatic ductal adenocarcinoma (PDAC) is a neoplastic disease which accounts for "90% of pancreatic malignancies," and has a 5-year survival rate of only 9%. The dismal nature of the PDAC diagnosis, which has a median survival time of about one year, can be attributed in part to late detection. In fact, the Cancer of Pancreas Screening-5 study demonstrated a 73.3% survival rate in participants whose PDAC was found early through surveillance via MRI and endoscopic ultrasound. This eightfold increase in survival rate suggests the inherent efficacy of PDAC screening, however, with the median cost of a full MRI being about $2,000, there is a significant barrier to entry for PDAC screening. As a result, finding a cost-effective alternative to PDAC screening could improve survival rates and lower costs, both directly and indirectly. Liquid biopsy could prove to be a valuable tool in the early diagnosis of PDAC, as it provides a non-invasive way to detect the presence of a disease state such as PDAC. Chromatin immunoprecipitation (ChIP), a type of liquid biopsy used to study protein-DNA interaction, is a promising method at the forefront of cancer research, and has been proven to be capable of detecting tumor-specific transcriptional activity. Additionally, the assay has shown promise in diagnosis and prognosis of disease state. Currently, few (if any) modalities of liquid biopsy in pancreatic cancer use ChIP, and other forms of liquid biopsy have proven to lack sensitivity and specificity. Thus, the aim of this research is to utilize the ChIP assay as a diagnostic and prognostic tool in PDAC by detecting and quantifying tumoral gene expression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32816
        • Recruiting
        • University of Central Florida

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The investigators want to control for approximate age and have two participants of each gender, and are looking to get 4 without Pancreatic Ductal Adenocarcinoma (PDAC), and 4 of each stage of PDAC (1 through 4).

Description

Inclusion Criteria:

  • 18 years old or older
  • Pancreatic cancer patients

Exclusion Criteria:

  • Children may not register
  • Persons who are unable to consent may not register

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pancreatic Ductal Adenocarcinoma
Other: Non-Human Subject Research study.
This is a Non-Human Subject Research study. There is no intervention. All participants are de-identified.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Level of c-ERBB1 in blood using Chromatin immunoprecipitation and Reverse transcription-quantitative polymerase chain reaction
Time Frame: 1 year
Chromatin immunoprecipitation is a method used to study the interaction between DNA and proteins. This makes it a valuable tool for detecting disease state in samples as it allows us to study gene regulation. To put this into practice, DNA is crosslinked to proteins and precipitated out of solution using an antibody. In this case, anti-H3K36me3 was used as it is a marker for active gene regulation which allows for separation of actively transcribed genes. This is synonymous to selecting for a certain disease state that is ongoing. Once this is done, Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) is run on the sample to select for EGFR c-ERBB1, which is an epithelial growth factor (EGFR) mutation which is present in 93% of PDAC cases. Analysis of relative levels of c-ERBB1 should allow for us to diagnose and prognose different stages of PDAC.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Central Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kersten Schroeder, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00005188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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